Regulatory Affairs Manager jobs
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SR. SPECIALIST, REGULATORY AFFAIRS CMC
Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...
| Company | Biospace |
|---|---|
| Address | United States |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 3 weeks ago See detail |
Sr. Specialist, Regulatory Affairs CMC
Biospace
United States
Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...
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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...
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Manager - AML Regulatory Compliance Consulting (Global Banks)
Rsm Global
New York, NY
Develop strong relationships with existing clients and prospective clients within banking and financial services industries to enable effective sales. Manage and deliver assessments and other services covering regulatory complianc...
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Sr. Manager Medical Affairs Strategy, PBC
Biospace
California, United States
Create, revise and maintain Medical Affairs slide decks.. Responsible for the development and execution of projects that will support and disseminate disease area background, medical questions or scientific data updates.. Serves a...
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- View all Biospace jobs - jobs in California State
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...
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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...
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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...
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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...
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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...
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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...
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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...
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- View all Biospace jobs - jobs in California State
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...
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Manager, Reg Affairs NAM
Iff Family Of Companies
Ridgefield, NJ
Responsible for the preparation of regulatory submissions including GRAS dossiers, NDIN, Master Files, FSRN and other relevant regulatory documents or submissions. Collaborate with internal IFF Global Regulatory Strategy Lead and...
2 weeks ago seen See more...
Casino Regulatory Manager
Commonwealth Of Massachusetts
Plainville, MA
Assist the Gaming Agents Division Chief with the creation of policies and procedures within the Investigations and Enforcement Bureau (IEB), Gaming Agents Division, recommend regulations, policies and procedures in order to improv...
3 weeks ago seen See more...
Summer 2024 - Regulatory Portfolio Management Internship
Bristol-Myers Squibb Company
Princeton, NJ
Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making, project availability d...
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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...
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Manager, Global Regulatory Policy
Hsbc
New York, NY
Support senior management to direct HSBC's response to the external regulatory consultation process Provide technical input into regulatory change projects and to participate in their working groups as appropriate Develop and main...
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Senior Manager, Product Communications and Public Affairs, Pulmonary Hypertension
Johnson & Johnson
Titusville, NJ
Develop and implement innovative communication and Public Affairs strategies and programs in support of brand business objectives for UPTRAVI, OPSUMIT, OPSYNVI. Lead the growth of unbranded social communities and content creat...
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Manager, Faculty Staff Affairs
Pix11
New York, NY
Provide leadership, day-to-day operational oversight, and management for the Project Coordinator Team, which supports the academic activities of the research enterprise.. Partner with Director to develop departmental policies and...
3 weeks ago seen See more...
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Director Regulatory Affairs
Paysafe
Jacksonville, FL
Bachelor's degree; advanced degree preferred. Minimum of 8 years of experience in Regulatory Affairs, compliance, or legal roles within the financial services industry, with a focus on payments, fintech, or e-commerce. Strong unde...
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Medical Affairs Operations Senior Manager-Americas (Hybrid)
Csl
Summit, NJ
Provide Medical Affairs (MA) project support regionally and engage team members to solicit project concerns and ideas for improvement. . Meet with MA Regional Head and Country Medical Leads to provide MA project status updates and...
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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...
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- View all Biospace jobs - jobs in Menlo Park, CA
Senior Manager, US Medical Advertising and Promotions Regulatory (GI)
Biospace
Lexington, MA
I further attest that all information I submit in my employment application is true to the best of my knowledge.About the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review, GI where you will be an interna...
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Project Manager-Regulatory
Ulteig
Rancho Cordova, CA
Provide project management support for large and complex projects. Support client with understanding of CA budget process and associated legislation. Virtually attend legislative hearings and provide briefings on relevant content....
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System Manager Cerner Quality and Regulatory Reporting
Commonspirit Health
Englewood, CO
Bachelors Degree required, Masters Degree preferred. 10 years healthcare experience required.. 5-7 years of leadership experience with direct reports required.. Healthcare Clinical Licensure required Nursing, pharmacy, therap...
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Director Regulatory Reporting - Sr. Group Manager
Citigroup
New York, NY
The GRR Group is a high-profile function, providing financial information to the regulators including the Federal Reserve Bank (FRB) and Office of the Comptroller of the Currency (OCC). This individual will have an opportunity to...
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Regulatory and Transaction Coding Manager
Wellsense Health Plan
Remote - Oregon, United States
Full-time remote work. Competitive salaries. Excellent benefits. Develops and maintains corporate transaction policies, and works collaboratively with stakeholders and department manager to ensure consistency with the Plans syste...
3 weeks ago seen See more...
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Senior Director, Regulatory Information Management
Biospace
Waltham, MA
Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...
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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...
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