- Insmed Incorporated (NJ)
- …readiness for both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our ... and analytical development.Demonstrated success in regulatory submissions and global CMC regulatory requirements.Experience managing external partners… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the Regulatory Affairs ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- …timelines, submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC , Clinical, Quality) to facilitate ... and QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements (FDA, EMA, Health Canada, MHRA,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs , Clinical, and Program Management.Maintain ... Legend Biotech is a global biotechnology company dedicated to treating, and one...research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our… more
- Unknown (Boston, MA)
- … CMC development programs. The ideal candidate will have a strong background in Regulatory Affairs CMC , with experience leading regulatory strategies ... Director will collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate… more
- Sanofi (Cambridge, MA)
- …with all key stakeholder in GPT and Global Brand Team (GBT) Defines global project plans and regulatory strategy together with the GPT members; leads the ... components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT.… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Parexel (Providence, RI)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Gilead Sciences, Inc. (Washington, DC)
- …A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC ... Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused...PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative… more
- Boehringer Ingelheim (Duluth, GA)
- …product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical biotech and ... Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Astellas Pharma (Northbrook, IL)
- …Regulatory Affairs , Quality Assurance, Business Partners). Responsible for developing regional/ global CMC regulatory strategy (eg, CMC ... apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with...**Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...initiatives internal to RA CMC . + Represents CMC regulatory affairs on project… more
- Organon & Co. (Jersey City, NJ)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …quality principles, and regulatory expectations to support relevant global regulatory submissions. + Authors, reviews and edits CMC sections and provides ... functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC...considerations via risk-based approaches. + Continually monitors the evolving global regulatory landscape regarding CMC … more
- Sanofi Group (Waltham, MA)
- …CMC dossiers. The CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading ... the preparation of CMC dossiers for regulatory submissions to enable...Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs + Skilled in AI applications… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
