Sr. Associate Regulatory Affairs
On-siteHyderabad, Telangana, India
Job Summary
Lead submission for annual reports, facility registrations, renewals, and product renewals while preparing content plans for CMC IND/CTAs, IDEs, marketing applications, and Module 3 baselines. Coordinate, prepare, and legalize country-specific CMC documents; archive submissions in the document management system and maintain product timelines. Interact with authors, reviewers, and subject matter experts to deliver required CMC and Device documents. Initiate and maintain timelines at the direction of the product lead, provide activity status reports, and participate in cross-functional special project teams. Train staff on select procedures and systems.
Required Qualifications
- Bachelor's degree
- 5-9 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Desired Qualifications
- BS degree in Life Science
- 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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