- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing ... regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership and strategy to achieve regulatory ... and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... 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 (San Diego, CA)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC ,… 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 ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Organon & Co. (Plymouth Meeting, PA)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to...participation in the annual bonus program. At the Associate Director level, the salary range for this position is… more
- Organon & Co. (Plymouth Meeting, PA)
- …development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing ... and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment Representative is...Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to… more
- BeOne Medicines (Emeryville, CA)
- …role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs , Quality, Safety/Pharmacovigilance, Clinical, CMC , and ... Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance initiatives,… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . -Applies the CSL Leadership Capabilities - Build Bridges,… 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
- AbbVie (North Chicago, IL)
- …. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… 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
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Boehringer Ingelheim (Duluth, GA)
- …marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical ... + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... **Overview** The Director , CMC provides leadership for the...Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sumitomo Pharma (Boise, ID)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
