Regulatory Affairs Manager

Lets do this. Lets change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgens CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level.

Additional job responsibilities include:

• Lead submission for annual reports, facility registrations, facility renewals, and product renewals
• Potential to oversee or manage staff
• Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams
• Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions
• Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications
• Coordination, preparation, collection and/or legalization of CMC country specific documents
• Document and archive CMC submissions and related communications in the document management system
• Initiate and maintain CMC product timelines at the direction of product lead
• Interface with the regulatory operations team
• Train staff on select CMC procedures and systems
• Provide report status of activities and projects to teams and department
• Participate in cross-functional special project teams

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR
• Masters degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
• Bachelors degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

• Experience managing or overing staff members
• Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
• Regulatory CMC specific knowledge and experience
• Mature project management and organizational skills
• Strong and effective oral and written communication skills
• Experience in Veeva Vault platforms