Manager, Regulatory Affairs jobs - Boston, MA

  Subscribe to RSS Feed
Post a Job Only $40 for 60 days
Posted Job Title Company Location

Looking to hire? Post your job today!
More Job Postings from the Web
Mar 20 Safety Regulatory Specialist Sepracor Marlborough, MA

Affairs to coordinate the associated regulatory documents and correspondence. ... Responsible for regulatory assessment of individual case safety reports to Regulatory... more

Mar 20 Manager, Regulatory Affairs Submission Biologics Biotech Company Boston, MA

provided JOB SUMMARY This Regulatory Affairs Manager position is for individuals ... in regulatory affairs in the submission of regulatory filings to the appropriate... more

Mar 20 Manager/Sr. Manager, Medical Affairs Sepracor Marlborough, MA

Manager, Medical Affairs Department Medical Affairs Location Marlborough, ... Effectively train/manage/mentor Medical Affairs Specialists; (30%); -Assist with the... more

Mar 20 Sr. Director Quality And Regulatory Affairs $40b Global Fortune 120 Boston, MA

thereby protecting the organization from regulatory legal action. Your ... working in quality and regulatory affairs within a global medical device... more

Mar 20 Sr. Mgr Regulatory Aff, Compliance Medical Device Biotech Medical Device Company Boston, MA

Manager, Regulatory Affairs, Compliance Medical Device Location: ... Regulatory Affairs and Company personnel on regulatory requirements and processes. more

Mar 20 Global Project Manager, Registry Investigator Programs Genzyme Cambridge, MA

to support site aspects of Registry related regulatory commitments, such as data ... to, Data Management, Regulatory, Medical Affairs, Clinical Research, Legal, Global... more

Mar 20 Customer Business Manager (Woonsocket, Rhode Island) Perrigo Company Woonsocket, RI

processes orders, working with Regulatory Affairs, Art, Accounting and other ... accounts. Issues which are referred to the manager include significant payment problems... more

Mar 20 Director, Clinical Relationship Management Boston, MA

medical writing, drug safety, and regulatory affairs and the specific challenges of outsourcing each of these activities.Ability to lead in a matrix environment.Excellent... more

Mar 20 ACRP - Medical Director/Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs * ... compound * Interface with international regulatory authorities, as appropriate, in... more

Mar 20 DIA - Medical Director/Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs Be ... and defending US IND's or similar ex-US regulatory submissions Preferred... more

Mar 20 Prin Program / Project Analyst Medtronic Surgical Technologies Littleton, MA

disciplines: product development, clinical, regulatory affairs, quality, operations, product planning and product marketing Position Responsibilities ?Takes projects from original... more

Mar 19 Regulatory Affairs Specialist Boston Scientific Marlborough, MA

for Regulatory Affairs support of submissions and on going regulatory ... or technical discipline. 2 4 years Regulatory Affairs experience, medical... more

Mar 19 Associate Directore State Government Affairs Daiichi Sankyo Boston, MA

Affairs to manage legislative and regulatory policy issues in the Northeast ... as a first-tier resource to legislators, regulatory officials, and patient advocacy... more

Mar 19 Manager Med Comm and Ed Genzyme Cambridge, MA

Medical Affairs The (Senior) Publications Manager in Biosurgery Medical Affairs will ... Sales, HEOR, Legal and Regulatory Affairs.Manage reports and vendors to... more

Mar 19 Medical Science Liaison - New England Medical Affairs Company Boston, MA

: Medical Science Liaison The Medical Affairs Company: Optimizing Scientific ... Opportunities Available The Medical Affairs Company (TMAC) is looking for... more

Mar 19 Sr Manager, Marketing Biogen Idec Wellesley, MA

with other functional areas (i.e.,Medical Affairs, Patient Services, MM&R, Commercial Training, Regulatory, Legal, and Sales) - Contribute to the development of presentation... more

Mar 19 Manager Med Comm and Ed Genzyme Cambridge, MA

Medical Affairs The (Senior) Publications Manager in Biosurgery Medical Affairs will ... Sales, HEOR, Legal and Regulatory Affairs.Manage reports and vendors to... more

Mar 19 Director, Clinical Relationship Management Millennium Pharmaceuticals Cambridge, MA

medical writing, drug safety, and regulatory affairs and the specific challenges of outsourcing each of these activities. Ability to lead in a matrix environment. Excellent... more

Mar 19 Drug Safety Associate II EMD Serono Rockland, MA

[USMI], US Quality Assurance [USQA], US Regulatory Affairs [USRA] and Global Drug ... * Detailed knowledge of FDA, EMEA and other regulatory authority regulations. * English... more

Mar 19 Oracle Clinical Global Librarian Tyco Healthcare Mansfield, MA

ORGANIZATIONAL RELATIONSHIPS/SCOPE: - Reports to manager of OC/SC Central Administration ... with team members with IS, QA, Regulatory, Medical Affairs, Clinical and... more

Mar 19 Medical Director, HCV Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs * ... trials * Contribute to the production of regulatory documents such as IND filings,... more

Mar 19 Nurse Reviewer II University of Massachusetts Medical School Boston, MA

First Shift Department: Office Of Clinical Affairs - W401300 Location: China Trade, 2 ... authorization for medical necessity within regulatory parameters/Medicaid Prior... more

Mar 18 Sr. Regulatory Affairs Associate ARIAD Pharmaceuticals Cambridge, MA

Regulatory Affairs: Formulate responses to regulatory inquiries Regulatory Affairs: ... Affairs: Negotiate regulatory approvals Regulatory Affairs: Define regulatory... more

Mar 18 Principal Regulatory Affairs Associate Genzyme Cambridge, MA

Principal Regulatory Affairs Associate Location: Massachusetts-Cambridge Genzyme ... global regulatory team in implementing the regulatory strategy to achieve timely filing... more

Mar 18 Manager, Regulatory Organogenesis Canton, MA

Manager, Regulatory Department: Regulatory Affairs Schedule: Full-time ... in the US and EMEA required (international regulatory affairs experience required). more

Mar 18 Regulatory Affairs Specialist Boston Scientific Marlborough, MA

Regulatory Affairs Specialist Requisition ID 32478 Full/Part Time x Location ... MA Description Summary Responsible for Regulatory Affairs support of submissions... more

Mar 18 Principal Regulatory Affairs Associate Genzyme Cambridge, MA

He/She will work with management and the business unit to construct world wide regulatory ... global regulatory team in implementing the regulatory strategy to achieve timely filing... more

Mar 18 Regulatory Affairs Specialist Boston Scientific Marlborough, MA

Responsible for Regulatory Affairs support of submissions and on going regulatory ... discipline. * 2 - 4 years Regulatory Affairs experience, medical industry... more

Mar 18 Safety Regulatory Specialist Sepracor Marlborough, MA

Affairs to coordinate the associated regulatory documents and correspondence. ... Responsible for regulatory assessment of individual case safety reports to Regulatory... more

Mar 18 AD Regulatory Affairs - Program and Information Technology Management Genzyme Cambridge, MA

activities. Responsibilities for Regulatory Information Management projects: ... implementation and upgrade projects for Regulatory and BMRA business processes. The... more

Mar 18 Vice President, Regulatory Affairs, CMC Genzyme Cambridge, MA

Vice President, Regulatory Affairs CMC Job Responsibilities/Department description: ... corporation. The Vice President, Regulatory Affairs -Chemistry, Manufacturing & Controls... more

Mar 18 Respiratory Solutions-Sr. Regulatory Affairs Specialist (09-2511) Covidien Norwood, MA

Regulatory environment. 6. Communicate with regulatory agencies on administrative and ... Author and/or review regulatory procedures and update as necessary... more

Mar 18 Associate Directore State Government Affairs Daiichi Sankyo Boston, MA

Affairs to manage legislative and regulatory policy issues in the Northeast ... as a first-tier resource to legislators, regulatory officials, and patient advocacy... more

Mar 18 Reg Affairs Assoc Principal Genzyme Cambridge, MA

an excellent opportunity for a Regulatory Affairs Professional who has previous ... are met. This person will represent Regulatory Affairs on interdisciplinary... more

Mar 18 Reg Affairs Assoc II Genzyme Cambridge, MA

in our continued success. The Regulatory Affairs Operations (RAOps) submission group ... with RAOps colleagues and Regulatory Affairs associates. Key... more

Mar 18 Manager/Sr. Manager, Medical Affairs Sepracor Marlborough, MA

Manager, Medical Affairs Department Medical Affairs Location Marlborough, ... Effectively train/manage/mentor Medical Affairs Specialists; (30%); -Assist with the... more

Mar 18 Associate Directore State Government Affairs Daiichi Sankyo Boston, MA

Affairs to manage legislative and regulatory policy issues in the Northeast ... as a first-tier resource to legislators, regulatory officials, and patient advocacy... more

Mar 18 Reg Affairs Assoc Senior - CMC Genzyme Framingham, MA

success. Working within the Regulatory Affairs CMC group, this position coordinates ... current regulatory knowledge and keeps abreast of regulatory procedures and... more

Mar 18 Reg Affairs Assoc Senior - Operations Genzyme Cambridge, MA

and sharing in our continued success. The Regulatory Affairs Operations (RAOps) ... of regulatory filings in coordination with Regulatory Affairs product associates. The... more

Mar 18 Director, Global Medical Affairs - Fabry Genzyme Cambridge, MA

(Associate) Director, Global Medical Affairs, leads key internal and external ... or pharmaceutical industry, with a medical affairs or medical communications... more

Mar 18 Manager Medical Marketing Organogenesis Canton, MA

Manager Medical Marketing Department: Marketing Schedule: Full-time Shift: Day Hours: 8 ... the Product Marketing group, Medical Affairs, the Sales group, the R&D group and... more

Mar 18 Sr Director, Medical Affairs Learning and Development Genzyme Cambridge, MA

Senior Director, Medical Affairs Learning and DevelopmentThe Director, Medical Affairs ... programs to serve the needs of Medical Affairs professionals.*Coordinate the... more

Mar 18 Business Development Manager Genzyme Cambridge, MA

diligence.* Assess & quantify market issues related to business opportunities. Work with departments such as Finance, Marketing, Medical, Regulatory Affairs, Science, Operations,... more

Mar 18 Manager Med Comm and Ed Genzyme Cambridge, MA

Medical Affairs The (Senior) Publications Manager in Biosurgery Medical Affairs will ... Sales, HEOR, Legal and Regulatory Affairs.Manage reports and vendors to... more

Mar 18 Product Manager Genzyme Cambridge, MA

regional marketing, medical marketing, regulatory and other departments to ... Sales Training, e-Business and Medical Affairs groups to align with the global... more

Mar 18 Global Sr. Project Manager, Registry Investigator Programs Genzyme Cambridge, MA

to support site aspects of Registry related regulatory commitments, such as data ... to, Data Management, Regulatory, Medical Affairs, Clinical Research, Legal, Global... more

Mar 18 Clincal Manager of Operations(RN) Andover to Boston Region Genesis Healthcare Andover, MA

SUMMARY: The Clinical Services Manager provides clinical leadership to ... Consults Medical Director and/or Vice President of Medical Affairs as necessary... more

Mar 18 Associate Director, Medical Research Biogen Idec Cambridge, MA

Clinical Operations, Program Management, Regulatory Affairs, Business Development, ... and in the preparation of worldwide regulatory submissions. The appropriate... more

Mar 18 VP, Global Head, Drug Safety & Risk Mgmt(Post Marketing) Biogen Idec Cambridge, MA

the principal contact with North American regulatory agencies for interactions ... also in Medical Research or Regulatory Affairs in the pharmaceutical/... more

Mar 18 Sr Manager, Drug Safety Quality Biogen Idec Cambridge, MA

departmental and contractor compliance with regulatory requirements, departmental ... industry in safety surveillance, regulatory affairs, quality assurance or... more

Mar 18 Clinical Research Specialist - Oncology ARIAD Pharmaceuticals Cambridge, MA

appropriate functions (e.g., regulatory affairs, clinical operations) in ... safety and pharmacovigilance, regulatory affairs and commercial... more

Mar 18 Director, Medical Research Biogen Idec Cambridge, MA

Clinical Operations, Program Management, Regulatory Affairs, Business Development, ... Affairs, Business Development, Medical Affairs and US and International commercial... more

Mar 18 Senior Staff / Principal Scientist, Analytical Dev ARIAD Pharmaceuticals Cambridge, MA

Controls (CMC) documentation required for regulatory submissions.Actively participate ... Quality Control/Quality Assurance, and Regulatory Affairs to facilitate the... more

Mar 18 Senior Director Medical (MD) Genzyme Cambridge, MA

She/he will build the CV medical affairs team and ensure that global medical affairs ... marketing, post-approval studies, Regulatory Affairs, and GCP). The ability to... more

Mar 18 Associate Director Sanofi-Aventis U.S. Cambridge, MA

and for the studies from the Global Medical Affairs (GMA) with Medico-marketing ... as Clinical Research, PharmacoVigilance, Regulatory, or in a CROor as a physician at... more

Mar 18 Business Analyst Senior Genzyme Cambridge, MA

and regulatory affairs groups (Biomedical, Regulatory Affairs - BMRA) with regards to planning, forecasting, resource management, and business operations Additionally, the... more

Mar 18 Continuous Process Improvement Analyst Genzyme Cambridge, MA

metrics across Biomedical Operations Regulatory Affairs (BMRA) (including; but not limited to, clinical, regulatory, data management and safety). He/she will be responsible for... more

Mar 18 Director BMRA Forecasting, Planning & Business Operations Genzyme Cambridge, MA

and regulatory affairs groups (Biomedical, Regulatory Affairs - BMRA) with regards to planning, forecasting, resource management, and business operations. Additionally, the... more

Mar 18 Medical Science Liaison Genzyme Cambridge, MA

including, but not limited to, Medical Affairs, Clinical Research, Patient ... all relevant company, industry, legal, and regulatory requirements. Job... more

Mar 18 Principal Compliance Specialist Genzyme Framingham, MA

with Manufacturing, Quality Control, Regulatory Affairs, QP, and Materials ... groupActively participates in audits from regulatory agenciesEnsure that documentation... more

Mar 18 Principal Compliance Specialist Genzyme Framingham, MA

with Manufacturing, Quality Control, Regulatory Affairs, QP, and Materials ... groupActively participates in audits from regulatory agenciesEnsure that documentation... more

Mar 18 Assoc Director Cont Proc Impv Genzyme Cambridge, MA

role in the BMRA Biomedical Regulatory Affairs (BMRA) Process Excellence ... in Pharmaceutical Research, Development and Regulatory Affairs and the ability to drive... more

Mar 18 Counsel, Intellectual Property Sepracor Marlborough, MA

Assist investigators and other Legal Affairs-IP personnel with preparation, ... and maintain Compliance with all applicable regulatory, legal and operational rules and... more

Mar 17 Director, Global Regulatory Affairs Neurodegenerative Diseases-1000310 Rockland, MA

Global Regulatory Affairs Neurodegenerative Diseases-1000310 EMD Serono, Inc. ... PURPOSE OF THE ROLE To develop global regulatory strategies for neurodegenerative... more

Mar 17 Dossier Manager Randstad Cambridge, MA

this capability. Working closely with the Regulatory Leads, the Dossier Manager will ... etc.) is highly desired; 4 years Regulatory Affairs or pharmaceutical... more

Mar 17 Dossier Manager Randstad Cambridge, MA

this capability. Working closely with the Regulatory Leads, the Dossier Manager will ... etc.) is highly desired; 4 years Regulatory Affairs or pharmaceutical... more

Mar 17 Sr. Manager, Product Development Biogen Idec Boston, MA

studies in ROW countries, including regulatory filings, Ethics Committee ... international clinical development or regulatory affairs. The candidate should... more

Mar 17 Senior Manager, Marketing - Tysabri Biogen Idec Boston, MA

Services, MM&R, Commercial Training, Regulatory, Legal, and Sales) - Contribute ... pieces materials through the medical, regulatory and legal promotional review... more

Mar 17 Clinical Research Manager Position Open Randstad Cambridge, MA

medical writing, drug safety, and regulatory affairs -Ability to lead a cross-functional team in a matrix environment -Excellent interpersonal and negotiation skills -Strong... more

Mar 17 Clinical Research Manager Position Open Randstad Cambridge, MA

medical writing, drug safety, and regulatory affairs -Ability to lead a cross-functional team in a matrix environment -Excellent interpersonal and negotiation skills -Strong... more

Mar 17 Sr Manager, Supply Chain Quality Biogen Idec Boston, MA

Control, Quality Assurance, Regulatory Affairs, and Drug Safety/Risk Management. ... goods distribution - Review/approve regulatory submissions - Participate in BIIB... more

Mar 17 Sr Manager, Drug Safety Quality Biogen Idec Boston, MA

departmental and contractor compliance with regulatory requirements, departmental ... industry in safety surveillance, regulatory affairs, quality assurance or... more

Mar 17 Senior Manager, Professional Marketing - Avonex Biogen Idec Boston, MA

Services, MM&R, Commercial Training, Regulatory, Legal, and Sales) - Contribute ... pieces materials through the medical, regulatory and legal promotional review... more

Mar 17 QA GCP Manager/Sr. QA GCP Manager Synta Pharmaceuticals Boston, MA

clinical operations, records management and regulatory affairs SOPs Coordinate internal ... documents that will be submitted to regulatory authorities (i.e., CSRs, clinical... more

Mar 17 Solution?s Consultant?eClinical Software Mrinetwork Klein Hersh International Boston, MA

working with clinical Software/eClinical/regulatory submission/Drug ... ECTD) quality management, regulatory affairs, regulatory operations and/or... more

Mar 17 Sr. Associate I, Drug Safety Quality Biogen Idec Boston, MA

industry in safety surveillance, regulatory affairs, quality assurance or ... knowledge of US, Canadian and international regulatory requirements. Interpersonal... more

Mar 17 Medical Director/Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs Be ... this compound Interface with international regulatory authorities, as appropriate, in... more

Mar 17 Medical Director/Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs Be ... and defending US IND's or similar ex-US regulatory submissions Preferred... more

Mar 17 Medical Director/Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs Be ... and defending US IND's or similar ex-US regulatory submissions Preferred... more

Mar 17 Design Assurance Engineer Millipore Billerica, MA

site quality, quality systems, regulatory affairs, external quality groups, ... of domestic and international quality and regulatory requirements (ICH and CFR),... more

Mar 17 Director Quality Beckman Coulter Danvers, MA

but training and certificates in quality or regulatory affairs would be a plus e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles Skills and attributes: Proven, effective... more

Mar 17 Associate Director Sanofi-Aventis Cambridge, MA

and for the studies from the Global Medical Affairs (GMA) with Medico-marketing ... as Clinical Research, PharmacoVigilance, Regulatory, or in a CROor as a physician at... more

Mar 17 Director of Quality Beckman Coulter Genomics Danvers, MA

but training and certificates in quality or regulatory affairs would be a plus e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles Skills and attributes: Proven, effective... more

Mar 16 Head of Medical Affairs Ironwood Pharmaceuticals Cambridge, MA

of clinical, biometric, and regulatory affairs (CBRA), will create and provide ... procedures (SOPs) governing medical affairs; - Partner, collaborate, and... more

Mar 16 Safety Regulatory Specialist Sepracor Marlborough, MA

Affairs to coordinate the associated regulatory documents and correspondence. ... Responsible for regulatory assessment of individual case safety reports to Regulatory... more

Mar 16 Reg Affairs Assoc Principal Genzyme Cambridge, MA

an excellent opportunity for a Regulatory Affairs Professional who has previous ... are met. This person will represent Regulatory Affairs on interdisciplinary... more

Mar 16 Reg Affairs Assoc II Genzyme Cambridge, MA

in our continued success. The Regulatory Affairs Operations (RAOps) submission group ... with RAOps colleagues and Regulatory Affairs associates. Key... more

Mar 16 Sr. Regulatory Operations Associate Vertex Pharmaceuticals Cambridge, MA

submissions by working with Regulatory Affairs strategy, Regulatory CMC, Medical ... regulatory submissions May supervise other Regulatory staff May assist more senior... more

Mar 16 Manager/Sr. Manager, Medical Affairs Sepracor Marlborough, MA

Manager, Medical Affairs Department Medical Affairs Location Marlborough, ... Effectively train/manage/mentor Medical Affairs Specialists; (30%); -Assist with the... more

Mar 16 Sr Director, Medical Affairs Learning and Development Genzyme Cambridge, MA

Sr Director, Medical Affairs Learning and Development Location: ... Senior Director, Medical Affairs Learning and Development The Director, Medical Affairs... more

Mar 16 Customer Business Manager (Woonsocket, Rhode Island) (2007842) Perrigo Company Woonsocket, RI

processes orders, working with Regulatory Affairs, Art, Accounting and other ... accounts. Issues which are referred to the manager include significant payment problems... more

Mar 16 Medical Director/Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs * ... compound * Interface with international regulatory authorities, as appropriate, in... more

Mar 16 Scientist - Bioassay Development Adnexus, A Bristol-Myers Squibb R&d Company Waltham, MA

Development, Discovery Research, Regulatory Affairs & QA, and the Non-Clinical ... Participate in corporate compliance/regulatory audits QA/QC Skills and... more

Mar 16 CLINICAL RESEARCH COORD. II Massachusetts General Hospital Charlestown, MA

* Maintains research data, patient files, regulatory binders and study databases per ... * Acts as liaison between Research Affairs and Unit * Submit all Institutional... more

Mar 16 Senior Scientist, Toxicology Vertex Pharmaceuticals Cambridge, MA

(formulations, analytical, ChemDev), Regulatory Affairs, Clinical Development, ... interactions (both written and verbal communications) with regulatory... more

Mar 16 Medical Director Sr Medical Director Vertex Pharmaceuticals Cambridge, MA

development department and internal regulatory affairs for assigned programs * ... compound * Interface with international regulatory authorities, as appropriate, in... more

Mar 16 CLINICAL RESEARCH COORD. II Massachusetts General Hospital Boston, MA

' Maintains research data, patient files, regulatory binders and study databases ' ... ' Acts as liaison between Research Affairs and Unit ' Files adverse events with... more

Mar 16 Associate Director Director, Global Trial Activation Group Vertex Pharmaceuticals Cambridge, MA

site identification, and investigator (regulatory) document management. Working in ... Activation Timelines, ICF development * Regulatory - Harmonization of Clinical Trial... more

Mar 15 Senior Regulatory Affairs Specialist Boston Scientific Marlborough, MA

and regulatory training/mentoring to other Regulatory Affairs employees and ... certification(s) preferred. * 5-8 years Regulatory Affairs medical industry... more

Mar 15 AD Regulatory Affairs - Program and Information Technology Management Genzyme Cambridge, MA

activities. Responsibilities for Regulatory Information Management projects: ... implementation and upgrade projects for Regulatory and BMRA business processes. The... more