- Merck & Co. (Rahway, NJ)
- … Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions , Strategic Thinking, Systems ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Upper Gwynedd, PA)
- …Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions , Technical Writing-Preferred ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Eisai, Inc (Nutley, NJ)
- …and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Planet Pharma (Princeton, NJ)
- …according to Style Guide. *As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ... issues. *Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM. *For clinical… more
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing… more
- Pall (Miami, FL)
- …for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions , negotiate the resolution of agency questions, and secure ... Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply to… more
- CorDx (Atlanta, GA)
- … Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and ... and external partners as needed. Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.… more
- BioSpace (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions . Solid working knowledge of drug development process… more
- Corcept Therapeutics (Redwood City, CA)
- …IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions , meeting requests, briefing books, annual reports/development ... strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions . This position will… more
- Intuitive (Sunnyvale, CA)
- …communication skills, proven ability to translate technical documentation into effective regulatory submissions Good interpersonal skills and able to work ... Company Description Job Description New Product/Indication Submissions Provide regulatory insight to development, new product introduction, and manufacturing… more
- Cleerly (Denver, CO)
- …States and account for geography when determining base salary. Responsibilities (General) Regulatory Submissions & Liaison: Prepare, review, and complete ... regulatory submissions to global regulatory agencies (eg, FDA, Health Canada, Europe), and communicate with regulatory authorities throughout the… more
- Stryker (Mahwah, NJ)
- …various Stryker divisions. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions , interact with ... of FDA, Europe, and international medical device regulations Experience drafting regulatory submissions for product approval Preferred RAC certification or… more
- Cedent (Boston, MA)
- …(eg, FDA, EMA). Coordinate and compile data from cross-functional teams to support regulatory submissions . Assist in the development of regulatory strategies ... to ensure compliance throughout the development lifecycle. Maintain up-to-date knowledge of regulatory changes and industry standards that impact submissions and… more
- Tandem (San Diego, CA)
- …filings and correspondence and/or approvals, including experience authoring a range of global regulatory submissions , (eg, 510(k), De Novo, CE Mark etc.) and ... preparing regulatory submissions to support product commercialization (eg, 510(k), CE Mark Technical File, International). Proficient knowledge of quality… more
- Michael Page (Skokie, IL)
- …integrate regulatory strategies into product development and go-to-market plans. Regulatory Submissions & Documentation: Prepare and maintain regulatory ... client is redefining the future of health and nutrition. Job Description Regulatory Compliance Oversight: Ensure all products comply with applicable regulations and… more
- Fate Therapeutics, Inc. (San Diego, CA)
- …extensive experience leading regulatory teams and a successful record of approved regulatory submissions . This is a full-time, exempt position located at our ... Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of… more
- IntePros (Audubon, PA)
- …of regulatory approval and tracking documents. Assemble documentation in support of regulatory submissions . Provide regulatory support as needed within ... regulatory files. Perform literature searches and extract information to support regulatory submissions . Assist with review of labeling and clinical reports… more
- Central Garden & Pet (Dallas, TX)
- …FDA Regulatory Affairs & Food Safety Develop content and format for regulatory submissions , such as amendments or supplements, for existing New Animal Drug ... opportunity for a skilled and experienced Food Safety and Regulatory Affairs (FSRA) Manager to join our team! This...team! This position reports to the Sr. Director, FDA Regulatory Affairs & Food Safety and will support all… more
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- … agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as ... Responsibilities: Complete and maintains regulatory approvals/clearances of heart valve replacement and repair...of heart valve replacement and repair devices, Represent the Regulatory function on manufacturing and product development teams to… more
- Abbott (Minneapolis, MN)
- …required for product market entry. What You'll Work On Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and ... get on with their lives. The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In… more
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