- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for… more
- BeiGene (Emeryville, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies ... remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects … more
- Amgen (Washington, DC)
- …regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and ... Product Lead is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate about ... and regulatory requirements. + Proven track record in supporting CMC programs from development to commercialization. + Experience in biotech, pharmaceutical, or… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …regulatory affairs + Has knowledge of fundamental understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology + Has ability to ... accountable for ensuring that stakeholders (including executives) are aligned; that regulatory agencies understand Takeda's CMC strategies through active… more
- J&J Family of Companies (Malvern, PA)
- Senior Engineering Manager - 2406214932W **Description** Johnson and Johnson is currently seeking a Senior Engineering Manager . At Johnson & Johnson, we ... Johnson & Johnson, we all belong. **Essential Job Duties and Responsibilities** The Senior Engineering Manager , Drug Delivery Systems (DDS), Johnson & Johnson… more
- Deloitte (Columbus, OH)
- …and create connections that empower a digitally enabled, equitable future of health As a Senior Manager in our AI & Data team are expected to contribute to ... 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory ... digital transformations / innovations + Submissions management, labeling, CMC change control and/or LCM processes + Veeva RIM… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- QC Stability, Senior Manager - Monroe, NC Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... oversight, and ensure compliance with internal procedures, industry regulations and regulatory guidance documents. Write, execute, and manage the stability program… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Integra LifeSciences (Plainsboro, NJ)
- …of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream leadership ... team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Senior Manager /Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion… more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible… more
- Bausch Health (Petaluma, CA)
- …with accuracy and in accordance with established procedures + Effectively communicates with Manager , team members, and Senior Management + Organized and able to ... impact. DESCRIPTION OF JOB: Creates and executes extensive analytical and CMC development plans for pharmaceutical active ingredients, excipients, oral and topical… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight on ... understand quality system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management to achieve alignment… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... federal and state compliance regulations. * Stays abreast of industry & regulatory changes impacting functional areas and revenue cycle. * Identifies potential… more