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Regulatory Affairs Project Manager jobs

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MANAGER, GLOBAL REGULATORY AFFAIRS CMC SUBMISSIONS MANAGEMENT

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...

CompanyBiospace
AddressLexington, MA
CategoryInformation Technology
Job typeFull time
Date Posted 10 hours ago See detail

Manager, Global Regulatory Affairs CMC Submissions Management New

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...

10 hours ago seen See more...

Senior Manager, Regulatory Affairs - General Medicine New

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...

10 hours 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 days 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...

5 days 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...

5 days ago seen See more...

Sr. Project-Program Manager, Regulatory Affairs

Arthrex

Naples, FL

Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.. Develops project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholde...

2 months 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...

2 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...

2 weeks 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...

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...

3 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...

3 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...

3 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...

3 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...

4 weeks 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...

a month 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...

a month 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...

a month 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...

Regulatory Affairs Manager Regional Regulatory Lead

Biospace

Washington, DC

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US. Provide content for and coordinate US regulatory documents and meetings in accordance with GRT s...

2 months ago seen See more...

Regulatory Affairs Manager

Freudenberg Group

Remote

$94.6K - $120K a year

Provide regulatory excellence to the organization and guide decision making Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and b...

2 months ago seen See more...

Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC

Boston Scientific

Saint Paul, MN

Oversite management of Core CRMRegulatory AffairsSustaining Program activities, with an emphasis on Leads and Lead accessories product portfolio. Manage a 3-4 person submissions team within a matrixed organization. Lead the CRM...

2 months 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...

4 weeks 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...

4 weeks 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...

4 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...

4 weeks 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...

4 weeks 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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