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Regulatory Affair Project Manager jobs

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SENIOR MANAGER, REGULATORY AFFAIRS PROJECT MANAGEMENT AND STRATEGIC PLANNING

You will lead cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase development programs by providing effective Project...

CompanyBiospace
AddressRemote
CategoryEngineering/Architecture/scientific
Job typeFull time
Date Posted 4 days ago See detail

Senior Manager, Regulatory Affairs Project Management and Strategic Planning

Biospace

Remote

You will lead cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase development programs by providing effective Project...

4 days ago seen

Sr Manager/AD Regulatory Affairs CMC (small molecules)

Biospace

San Francisco, CA

Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions. Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulato...

2 days ago seen See more...

Manager, Global Regulatory Affairs, Marketed Products

Biospace

Boston, MA

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with TakedasPrivacy Noticeand Terms of U...

3 days ago seen See more...

Senior Manager, Public Policy, International Government and Regulatory Affairs (IGRA)- Hybrid

Biospace

Rockville, MD

We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abiliti...

4 days ago seen See more...

Manager, Global Regulatory Affairs CMC Submissions Management

Biospace

Lexington, 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 Submissions Management in...

a week ago seen See more...

Senior Manager, Regulatory Affairs - General Medicine

Biospace

Basking Ridge, NJ

Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...

a week ago seen See more...

Regulatory Affairs Manager

Amgen

Washington, DC

Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.. Develops the international regulatory strategy and contributes to global regulatory plans.. Support regulatory product compli...

2 weeks ago seen See more...

Manager Regulatory Affairs

Teva Pharmaceuticals

Parsippany, NJ

Requires a Bachelors degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage form experience...

2 weeks ago seen See more...

Senior Manager CMC Regulatory Affairs

Biospace

Basking Ridge, NJ

Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...

2 weeks ago seen See more...

Manager, Global Regulatory Affairs, Marketed Products - Now Hiring

Takeda Pharmaceutical

Bronx, NY

$186,000 per year

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and. I further attest that...

3 weeks ago seen See more...

Manager, Global Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

$133,200.00 to $223,200.00 per year

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...

Quality & Regulatory Project Manager

Abbott Laboratories

Illinois, United States

$95,000 - $190,000 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

4 weeks ago seen See more...

Regulatory Affairs Manager (CMC Site)

Biospace

New Albany, OH

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...

a month ago seen See more...

Regulatory Project Management Consultant (Part-Time Contract)

Biospace

Menlo Park, CA

Coordinate and review regulatory submissions for global and US markets, including INDs and CTAs, and annual reports, in collaboration with regulatory lead and cross-functional teams. Develop and maintain regulatory documents, such...

2 months ago seen See more...

Regulatory Affairs Manager - Now Hiring

Abbott Laboratories

Texas, United States

$95000 - $190000 per year

Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...

2 months ago seen See more...

Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience

Biospace

Remote

As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and...

2 months ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Pix11

New York, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs/products of high complexity are established and maintained, and plans & directs the seamless e...

2 months ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Takeda Pharmaceutical

Brooklyn, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless...

2 months ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Takeda Pharmaceutical

Bronx, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless...

2 months ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

4 weeks ago seen See more...

Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring

Takeda Pharmaceutical

New York, United States

$138,500 - $186,000 per year

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 Submissions Management in...

4 weeks ago seen See more...

Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination

Biospace

North Chicago, IL

Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...

4 weeks ago seen See more...

Regulatory Operations Project Manager - OneSource Regulatory

Onesource Regulatory

Chicago, IL

$102K - $129K a year

Regulatory Operations service provider to over 100 small to large sized companies Process Optimization. System Implementations. Document Management. Submission Management. Publishing. Archiving. RIM. Submission Managers. Publisher...

4 weeks ago seen See more...

USA Regulatory Affairs Specialist Project Lead I Scientific

Adecco

Bridgewater, NJ

$ 88 - $ 89.22 / Hour

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

a month ago seen See more...

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

a month ago seen See more...

Associate Manager, Regulatory Affairs (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...

a month 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...

a month ago seen See more...

Manager, Regulatory Affairs- North America (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Mentoring and working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulator...

a month ago seen See more...

Manager, CMC Regulatory Affairs - Remote OR West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...

a month ago seen See more...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

New York, NY

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...

a month ago seen See more...

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What companies are hiring for Regulatory Affair Project Manager jobs?

The top companies hiring now for Regulatory Affair Project Manager jobs are Medpace, Inc., Medpace, Inc., UCLA Health,

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