Regulatory Affairs Mgr

king to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality, and countries.

The ROOTS2 staff member 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 and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market 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 and/or Device submissions and related communications in the document management system

• Initiate and maintain CMC product and/or Device 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

Basic Qualifications:

• Doctorate degree OR

• Master's degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR

• Bachelor's degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

• BS degree in Life Science

• Experience managing or hovering staff members

• Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development

• Experience in IVD, Device or Combination Product regulatory submission process

• 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

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