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Regulatory Affairs Director jobs in Suffolk, MA

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REGULATORY AFFAIRS DIRECTOR, ONCOLOGY

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

CompanyAstrazeneca
AddressWaltham, MA
CategoryInformation Technology
Date Posted 2 weeks ago See detail

Regulatory Affairs Director, Oncology

Astrazeneca

Waltham, MA

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

2 weeks ago seen See more...

Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology

Astrazeneca

Boston, MA

Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...

2 weeks ago seen See more...

Director, Regulatory & Quality Affairs

Mdc Associates

Beverly, MA

Direct and coordinate MDCs Regulatory Affairs activities. Collaborate with other MDC departments including Clinical Affairs and Quality Systems to ensure continuity of service across client projects. Support business development...

2 months ago seen See more...

Sr. Regulatory Affairs Specialist (Andover or Mansfield, MA)

Smith & Nephew

Andover, MA

$115,000 - $130,000 a year

Coordinates associated registration or submissions leading to market clearance/approval. Provide regulatory direction to project teams for product development/design control related activities. Drafting, authoring and submitting P...

2 weeks ago seen See more...

Senior Manager/Associate Director, Regulatory Strategy

Biospace

Boston, MA

Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the development of therapeutics to address theunderlying causes of these debilitating diseases. You will develop and implement...

2 weeks ago seen See more...

Regulatory Affairs Specialist - Labeling

Nesco Resource

Andover, MA

Up to $38.46 •

Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.. Initiates, reviews and a...

3 weeks ago seen See more...

Manager, Global Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

3 weeks ago seen See more...

Director, Global Medical Affairs Lead

Biospace

Waltham, MA

Serve as a medical subject matter expert on ASOs and other therapeutic modalities for our NMD programs. Serve as internal expert on medical literature / data associated with our NMD programs. Represent GMA on cross-functional team...

2 weeks ago seen See more...

Manager, Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

a month ago seen See more...

Manager, Regulatory Affairs CMC

Takeda Pharmaceutical

Boston, MA

$133,000 - $209,000 a year

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

2 months ago seen See more...

Director, Global Regulatory Lead (Oncology)

Biospace

Boston, MA

Interfaces with the LRST and AST to lead and support cross-functional company objectives.Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for developmen...

4 weeks ago seen See more...

Associate Director, Congress Strategy Lead, Global Medical Affairs Oncology

Biospace

Boston, MA

Co-develop Oncology external engagement strategy and lead the development of the cross-portfolio Congress Strategy and narrative for global congresses.. Liaise cross-functionally within Global Medical Affairs Oncology, and with OT...

a month ago seen See more...

Director of Special Projects-Academic Affairs

Bunker Hill Community College

Boston, MA

Participate in grant proposal meetings for new initiatives. Conduct research for proposals, including outreach to faculty and staff. Support completion of grant proposals in collaboration with Grants Office and BHCC Foundation. Co...

a month ago seen See more...

DIRECTOR OF GRADUATE STUDENT SUPPORT, Associate Provost for Graduate Affairs

Boston University

BOSTON, MA

The Director will be an experienced student affairs leader well-versed in current trends of higher education, able to identify and respond to emerging needs in graduate education through developing programs, collaborative projects...

a month ago seen See more...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

2 months ago seen See more...

Regulatory Affairs Specialist

Teleflex

Chelmsford, MA

$90,000 - $110,000 a year

Obtain timely market authorizations for Interventional products. Ensure regulatory requirements are met for quality systems, labeling, and promotional materials. Assess the impact of proposed regulations and guidance documents on...

2 months ago seen See more...

Regulatory Affairs Manager

Pramand Llc

Bedford, MA

$97.2K - $123K a year

Regulatory Strategy Formulate and execute regulatory strategies to assure timely and successful product approvals. Provide regulatory guidance to crossfunctional teams to support product development and commercialization. Regula...

2 months ago seen See more...

Sr. Regulatory Affairs Manager

Mass General Brigham Health Plan

Somerville, MA

$129K - $163K a year

Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on...

2 months ago seen See more...

Senior Director, Regulatory Information Management

Biospace

Waltham, MA

Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...

4 weeks ago seen See more...

Senior Director, Corporate Legal Affairs (Hybrid)

A Precision Therapy Company

Cambridge, MA

Handle SEC and Nasdaq reporting and compliance, including drafting 10-K, 10-Q, 8-K, S-3, S-8, annual meeting, and Section 16 filings. Partner with cross-functional teams to review press releases, scripts, medical meeting materials...

a month ago seen See more...

Associate Director, Global Regulatory Labeling

Biospace

Cambridge, MA

Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.. Direct the labeling control process for tracking, implementation, and regu...

a month ago seen See more...

Director, Global Medical Affairs - Oncology

Biospace

Cambridge, MA

Provide subject matter area expertise and leadership for cross-functional internal workstreams including Pharmacovigilance, Biostatistics, Clinical Operations, Regulatory Affairs and Brand teams.. Develop and foster relationships...

2 months ago seen See more...

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