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Full-Time Director Of Regulatory Affair jobs

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS INNOVATION

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

CompanyBiospace
AddressIrvine, CA
CategoryInformation Technology
Job typeFull time
Date Posted 7 days ago See detail

Associate Director, Regulatory Affairs Innovation

Biospace

Irvine, CA

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

7 days 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...

7 days ago seen See more...

Director, Clinical Regulatory Affairs

Cymabay Therapeutics

Newark, CA

Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...

4 weeks ago seen See more...

Director, CMC Regulatory Affairs Biologics

Biospace

California, United States

Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...

a month ago seen See more...

Director, Global Regulatory Affairs (GRL)

Biospace

Basking Ridge, NJ

Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...

2 months ago seen See more...

Associate Director, US Regulatory Affairs Strategy

Daiichi Sankyo, Inc.

Basking Ridge, NJ

Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...

2 months ago seen See more...

Director, Science & Regulatory Affairs

Biotechnology Innovation Organization

Washington, DC

Excellent communications skills, including writing and speaking skills Background in biology, drug development, and the life sciences Excellent research skills, including problem-solving ability and attentiveness to detail Ability...

2 months ago seen See more...

Director of Regulatory Affairs

University Of Advancing Technology

Tempe, AZ

Routinely review documents and conduct quality checks while verifying compliance and regulatory mandates are met. Develop and execute regulatory strategies to support product development, registration, and commercialization plans....

2 months ago seen See more...

Senior Advisor/Director, Global Regulatory Affairs – CMC

Biospace

Indianapolis, IN

Deep technical knowledge of synthetic molecule CMC drug development science(s). Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations. Development...

2 months ago seen See more...

Director of Regulatory Affairs

University Of Advancing Technology

Tempe, AZ

Routinely review documents and conduct quality checks while verifying compliance and regulatory mandates are met. Develop and execute regulatory strategies to support product development, registration, and commercialization plans....

2 months ago seen See more...

Director, Regulatory Affairs

Byheart

New York, NY

The only U.S.-made infant formula to use organic, grass-fed whole milk. The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list. T...

3 weeks ago seen See more...

Sr. Director, Regulatory Affairs

Biospace

San Diego, CA

Develop, implement and maintain regulatory and quality assurance strategies and activities for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies...

3 weeks ago seen See more...

Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs Advertising and Promotion

Biospace

California, United States

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

3 weeks ago seen See more...

Associate Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

3 weeks ago seen See more...

Director State Government Affairs (Remote)

Genentech

Washington, DC

$199K - $252K a year

Develop and lead the organization's state lobbying strategies for half of the United States on behalf of Roche Diagnostics.. Create strategic alignment between the interests of business areas and our lobbying and reimbursement act...

yesterday seen See more...

Associate Director - Regulatory Affairs - AD Promo

Biospace

Princeton, NJ

Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...

3 weeks ago seen See more...

Director, Public & Government Affairs

Nascar

Daytona Beach, FL

Identify, monitor, track and forecast public policy issues related to the organizations business interests. Prepare regular briefings and communications analyzing policy related matters for internal and external stakeholders Mana...

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Director, Regulatory Affairs, Oncology - Job ID: 1311

Ascendis Pharma

Palo Alto, CA

Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....

4 weeks ago seen See more...

Director Regulatory Affairs *Remote*

Providence

Beaverton, OR

Be responsible for managing and developing a team tasked with performing regulatory consulting and regulatory product lifecycle support for all Providence Health Plan and Providence Health Assurance business activity and strategic...

4 weeks ago seen See more...

Director, Regulatory Affairs Strategy, Hematology

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

4 weeks ago seen See more...

Director, Regulatory Affairs Strategy, Hematology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

4 weeks ago seen See more...

Director Regulatory Affairs

Nikang Therapeutics Inc

Wilmington, DE

Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...

4 weeks ago seen See more...

Director, Regulatory Affairs - Pharmaceuticals

Stryker

Mahwah, NJ

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...

4 weeks ago seen See more...

Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance

Ferring Pharmaceuticals

Parsippany, NJ

Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...

4 weeks ago seen See more...

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