- Gilead Sciences, Inc. (Foster City, CA)
- … Information Management system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC RA) or other relevant ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director, Regulatory Affairs - CMC (Manufacturing)** . This position will ... report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… more
- Merck (Madison, WI)
- **Job Description** **Director, Combination Product Regulatory CMC - (R5)** This Principal Scientist position is equivalent to a Director position. Under ... direction from the Combination Product Regulatory CMC Team Leader, the Principal Scientist...Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more} **Preferred… more
- BeOne Medicines (Emeryville, CA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Actalent (Bridgeton, MO)
- Job Title: Experienced Regulatory Affairs Specialist Job Description The Regulatory Affairs Specialist is responsible for ensuring compliance with ... relevant regulatory reporting requirements and preparing quality and timely CMC submissions to the US FDA Center of Veterinary Medicine (CVM). This role involves… more
- Lilly (Carolina, PR)
- …the world. The Sr. Principal Scientist **or** Advisor Post Approval Scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... for people around the world. Lilly is looking for post approval regulatory CMC (Chemistry, manufacturing and controls) scientists to join us in delivering… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …team and provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and ... + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC ) for investigational and commercial products +… more
- Actalent (Bridgeton, MO)
- …Center for Veterinary Medicine (CVM). Key Responsibilities: + Prepare and submit CMC post-approval submissions and regulatory correspondence to CVM, adhering to ... This role is responsible for ensuring compliance with all relevant regulatory reporting requirements and for preparing timely, high-quality post-approval Chemistry,… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or Morristown,… more
- Fujifilm (College Station, TX)
- …of an individual's development plan. Regulatory Affairs supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies' ... **Position Overview** **Summary:** The Quality Assurance Regulatory Affairs Supervisor is responsible for...products, summarize regulatory intelligence, provides CMC regulatory … more
- Merck (Austin, TX)
- …Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory Compliance, ... This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility… more
- Sanofi Group (Morristown, NJ)
- …strategy; in collaboration with R&D functions, Industrial Affairs , Global Regulatory Affairs . + Coordinate the submission of CMC regulatory files and ... thought was possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects… more
Related Job Searches:
Affairs,
Associate Regulatory Affairs CMC,
CMC,
CMC Regulatory,
Director Regulatory Affairs CMC,
Global Regulatory Affairs CMC,
Manager Regulatory Affairs CMC,
Regulatory,
Regulatory Affairs,
Regulatory Affairs CMC Specialist