Full-Time Regulatory Affair Director jobs

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SR MANAGER/AD REGULATORY AFFAIRS CMC (SMALL MOLECULES)

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...

CompanyBiospace
AddressSan Francisco, CA
CategoryInformation Technology
Job typeFull time
Date Posted 4 days ago See detail

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...

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...

Director - Market Access and Public Affairs Execution

Biospace

Plainsboro, NJ

Business planning & execution:. Develop complimentary target lists and call plans to ensure a coordinated and synergistic MAPA approach to market development and stakeholder engagement. Leads the planning and execution of National...

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...

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...

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...

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...

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...

Director - Head of Government Affairs

Dropbox

United States

In coordination with the Head of Global Public Policy and Government Affairs, develop a sophisticated and holistic advocacy plan for Dropboxs policy positions at the U.S. federal level and in other key markets in Latin America. A...

Director Medical Affairs Strategy, PBC

Biospace

California, United States

Regular communication with the Gilead Medical Scientist Liaison (MSL) team to remain current on issues in the field (gather insights) and to provide medical education, support, and direction.. Conducts advisory boards to collect f...

Director, Governmental Affairs

University Of Maryland Baltimore

Baltimore, MD

Acts as a primary contact between elected officials and the University to advocate for policies that advance the educational, research, clinical, and service mission of the University. Consults with University officials to develop...

Medical Director, Medical Affairs- Dermatology

Biospace

Illinois, United States

Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports across different products. Participation in design and execution of clinical trial safety, product s...

Corporate Affairs Associate Director- Oncology

Biospace

Washington, DC

Responsible for developing communication plans and materials that will drive awareness of data milestones, approvals, data publications and launches for priority assets in close partnership with the relevant Global/Regional Corpor...

Assistant Director, Office of Postdoctoral Affairs

York University

New York, NY

$120,000 - $140,000 a year

Career and academic counseling, excellent communication and interpersonal skills; ability to interact professionally with University academic and administrative community, and a demonstrated ability to work with all levels from di...

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...

Director Federal Government Affairs

Philip Morris

Washington, United States

So, wherever you join us, youll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.PMIs Federal Government Affairs is a growing team,...

Global Senior Director Medical Affairs (GDMA) – Daiichi Alliance, Oncology

Merck Sharp & Dohme

Rahway, NJ

$200,200 - $315,100 a year

The Global Senior Director Medical Affairs (GDMA) is responsible for driving execution of scientific & Medical Affairs plans for their assigned Therapy Areas (TA) in key countries and regions. They are impactful members of Product...

Senior Director, Public Affairs

Biospace

Washington, United States

Develop and lead environment crafting communications campaigns and activities for priority policy goals with GPP, Legal, FGA, LVA and the BUCAs. Collaborate with partners within Global Corporate Communications, (Corporate Channe...

Medical Affairs-Scientific Director CV Renal

Biospace

Plainsboro, NJ

Identify and anticipate potential trends, changes to market conditions and areas of opportunity aligned with Therapeutic Area priorities. Utilizes subject matter expertise and analytical tools to provide deeper customer knowledge...

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...

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...

Head of Regulatory Affairs Policy & Regulatory Intelligence

Biospace

Thousand Oaks, CA

Lead teams of policy experts and subject matter experts to accomplish policy goals. Recruit and retain highly qualified and diverse professional policy and Regulatory Intelligence professionals, ensuring they are appropriately qua...

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...

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...

Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH

Abbott Laboratories

Lake Forest, IL

$72,700 - $145,300 a year

Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...

Senior Associate - Regulatory Affairs

Biospace

Princeton, NJ

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

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...

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...

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...

Regulatory Affairs Consultant

Katalyst Healthcares And Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...