Regulatory Affairs Mgr

2 days ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

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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