- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Actalent (Bothell, WA)
- Description + Support preparation, review, and submission of CMC sections for US and global regulatory filings, including INDs/CTAs, amendments, and BLAs/MAAs. + ... with internal procedures. + Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function. Additional Skills & Qualifications + 3… more
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
- Actalent (Grand Rapids, MI)
- Job Title: Regulatory Affairs SpecialistJob Description The Senior Regulatory Affairs Specialist /Compliance Specialist /QA Specialist oversees ... requirements to stakeholders to maintain compliance without business delays. + Provide regulatory CMC support, including document preparation for filings and… more
- Merck (West Point, PA)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... supplies. + Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply and/or… more
