- Gilead Sciences, Inc. (Foster City, CA)
- …liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** ... **Key Responsibilities:** The Director , CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global CMC ** **What you will do** Let's do ... years of regulatory experience **Preferred Qualifications:** + Substantial experience leading CMC Regulatory Affairs strategy and execution for biologic… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** ... Incentive Plan for eligible positions + Referral bonus program \#LI-SS Category Regulatory Affairs CMC Astellas is committed to equality of opportunity in… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. **Job… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product… more
- Actalent (Gaithersburg, MD)
- …Masters, PharmD, or PhD preferred. + Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... + Must be located in EST time zone Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- AbbVie (North Chicago, IL)
- …to support regulatory submissions. + Work closely with Regulatory Affairs to ensure alignment of expectations for CMC control strategies in submissions. ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead...team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory … more
- AbbVie (Boston, MA)
- …with key business stakeholders including Development Sciences, Quality Assurance, Regulatory Affairs and others at the Director and VP level + Collaborate ... improvements, and drug substance tech transfers. Responsibilities: + Lead cross-functional CMC team(s) in authoring sections of regulatory documents, including… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Boehringer Ingelheim (Ridgefield, CT)
- …or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a ... Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will require the Fellow… more
- Danaher Corporation (Chicago, IL)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc. + Primary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Associate Director , Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies ... Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device regulatory strategies and activities… more
- J&J Family of Companies (Raritan, NJ)
- Sr. Director Medical Affairs TA Leader XTA - 2406217684W **Description** At Johnson & Johnson, we believe health is everything. Our strength in healthcare ... + Accountable for the delivery of the TA portfolio and ensures risk ( regulatory , CMC and/or clinical) mitigation/escalation and mitigation of critical issues… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. ... 35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The… more