- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Lilly (Philadelphia, PA)
- …make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and… more
- Lilly (Philadelphia, PA)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the ... preparation and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.… 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
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and ... + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Manager , Clinical Drug Supply & Logistics provides support for and may be responsible for forecasting Investigational Product (IP) supply ... managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager / Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new market launch… more
- Sumitomo Pharma (Nashville, TN)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical ... closely with program management, clinical development, PV, Biostat/Data Management, CMC , Biomarker/Translational Research, preclinical DMPK, etc to formulate clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Amgen (Thousand Oaks, CA)
- …transform the lives of patients while transforming your career. **Regional Operations Lead Manager ** **What you will do** Let's do this! Let's change the world! As ... Amgen expands globally, the Regional Operations Manager is a key position in implementing the Latin-America-Canada (LACAN) Region's commercial strategy, product… more
- Takeda Pharmaceuticals (Exton, PA)
- …with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 10 years' experience as ... studies) programs in accordance with internal and external legal, compliance and regulatory guidelines and in alignment with USM strategy and TA medical strategies.… more
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