Sr. Associate Regulatory Affairs

Amgen

1 - 2 years

14 - 16 Lacs

Hyderabad

Posted:2 days ago| Platform:

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Skills Required

Biotechnology Manager Quality Assurance Project management Analytical Pharma qaqc CMC Manager Quality Control Regulatory affairs Product support

Work Mode

Work from Office

Job Type

Full Time

Job Description

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
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, 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 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

Basic Qualifications:

Master s degree OR
Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
OR
High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

BS degree in Life Science
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

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