- Merck (Rahway, NJ)
- …preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with ... seamless communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting ... **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance . Ability to draw from ... a GRA CMC member, ensures and / or enhances regulatory compliance . + Ensures project team colleagues,...regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits ... on cross-functional teams to address regulatory issues. + Provide Regulatory Guidance and Compliance Oversight: Offer strategic regulatory advice… more
- Fresenius Medical Center (Waltham, MA)
- …high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... advocate for regulatory positions, influence decisions, and expedite approvals. + Regulatory Risk Management & Compliance : + Identify and manage … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …years' relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- American Water (Camden, NJ)
- …rate issues are in compliance with US GAAP and ensures overall regulatory compliance . Collaborates with treasury to assess state financing needs consistent ... to grow professionally! _ *Primary Role*_ Key member of regulatory services leadership team. Leads a team of geographic...Develops Talent Plans, Aligns, & Directs Drives Engagement Decision Quality * Join American Water We Keep Life Flowing*… more
- Chiesi (Cary, NC)
- …communications including social media, press releases, and talking points + Ensures regulatory compliance while effectively managing business risks + Understands ... regulatory guidance documents and initiating changes in systems to ensure regulatory compliance . Knowledge of Common Technical Document and global guidelines… more
- Organon & Co. (Jersey City, NJ)
- …to disseminate to senior leadership for further action. + Establish an international regulatory intelligence and policy network to ensure compliance with local ... **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global ...for achieving R&D goals and objectives in a high quality and cost-effective manner. **Required Education, Experience and Skills**… more
- USAA (San Antonio, TX)
- …with internal practices, risk and compliance policies and procedures, and regulatory requirements for quality management. **We offer a flexible work ... individual who has P&C Underwriting and Underwriting Technical and Compliance Quality Assurance experience only for this...Assurance experience only for this role.** As a dedicated ** Director , Quality Assurance** , you will lead… more
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