- Bristol Myers Squibb (Indianapolis, 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
- 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
- Lilly (Indianapolis, IN)
- …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
- 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
- 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
- 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 ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… 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 (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... 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 to… more
- Lilly (Indianapolis, IN)
- …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
- 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 ... guidances, and communicates changes in regulatory CMC information to project teams and senior ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Ascendis Pharma (Palo Alto, CA)
- …we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned ... devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in...share risks and achievements with Submission team, sub-teams, and senior management Requirements + Advanced degree (Master's or PhD)… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …and demand integrity and respect in all we do, create and deliver. The Senior Director, Medical Affairs supports the Medical Affairs department in ... are not limited to the Following Areas of Medical Operations: + Medical/Legal/ Regulatory Review + External Scientific communications + Scientific Publications + MSL… more
- System One (Florham Park, NJ)
- …documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance, to ... Job Title: Regulatory Operations Senior Publisher - Contractor...+ Ability to work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- AbbVie (North Chicago, IL)
- …programs developed internally, partnering closely with Drug Substance, Drug Product, Regulatory Affairs , QA and Process Development Sciences & Technology. ... + Author CMC analytical sections of IND/IMPD filings and contribute to global regulatory strategy alongside Reg Affairs . + Collaborate daily with DS, DP, QA,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Clinical Research and program management experience working with clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... Medical IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from… more
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