Amgen

Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information

Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations

Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry

Provide technology delivery leadership and domain expertise for Biological Studies product teams that enable in silico, in vitro and in vivo experimentation. Partner with Research and Technology leaders to create technology delivery strategy and prioritized agenda for Biological Studies.

Sr. Associate QA position will implement internal collaboration with Amgen’s global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. The role will support right-first-time quality systems activities

Support the Quality vision and mission for Amgen India aligned with Amgen’s mission to serve patients. Support Amgen India Quality Team Lead in the development and implementation of a multi-year Quality technological plan aligned with Amgens standards and overall strategic imperatives.

interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.

To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members.

Sales, marketing and/or clinical experience within pharmaceutical, biotech, diagnostics, healthcare insurance, pharmacy services, healthcare medical device or medical supply industries