Regulatory Affairs 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...
| Company | Biospace |
|---|---|
| Address | San Francisco, CA |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 18 hours ago See detail |
Sr Manager/AD Regulatory Affairs CMC (small molecules) New
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...
18 hours ago seen See more...
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Executive Director, Regulatory Affairs
Amgen
Los Angeles, CA
Provide management and leadership of regulatory strategy within the assigned therapeutic area for Global Regulatory Affairs. Direct the development of global and United States regulatory therapeutic area and product regulatory str...
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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...
2 days ago seen See more...
- View all - jobs in Boston, MA
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...
3 days ago seen
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...
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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...
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Director, Regulatory Affairs Vaccines CMC
Biospace
Boston, MA
Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed. Participate in...
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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...
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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...
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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...
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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...
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Associate Director, Regulatory Affairs (Advertising and Promotion)
Bausch Health
Bridgewater, NJ
Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...
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Director or Senior Director, Regulatory Affairs
Veranex, Inc.
San Jose, CA
$165,000 - $263,000 a year
Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...
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Regulatory Affairs Specialist III
Boston Scientific
Maple Grove, MN
Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...
2 weeks ago seen See more...
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Senior Product Stewardship & Regulatory Affairs Specialist Job
Arkema
United, PA
Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...
3 weeks ago seen See more...
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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...
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VP/TA Head, General Medicine - Global Regulatory Affairs
Merck
Rahway, NJ
Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...
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Regulatory Affairs Intern (Onsite)-Summer-Fall 2024
Becton Dickinson
Covington, GA
Assist with product submissions and regulatory assessments. Ensure compliance with all relevant regulatory requirements. Improve departmental procedures and processes. Assist with regulatory assessments for design change and non-d...
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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...
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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...
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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...
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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...
4 weeks ago seen See more...
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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...
4 weeks ago seen See more...
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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...
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Regulatory Affairs Specialist
Convatec
Lexington, MA
$49.4K - $62.5K a year
Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports Providing strategic product direction to teams on interaction and negotiating evidence with re...
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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...
4 weeks ago seen See more...
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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...
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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...
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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...
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