Senior Manager, Global Regulatory Affairs
$15,000–$25,000 year
On-site · Hyderabad, Telangana, India
Job Summary
The Senior Manager of Global Regulatory Affairs will lead strategic and operational aspects of regulatory submissions and compliance across international markets. Key responsibilities include managing regulatory submissions for complex solid oral dosage forms and injectables, providing regulatory guidance to cross-functional teams, monitoring global regulatory changes, and ensuring compliance with country-specific regulatory requirements. The role also includes mentoring a team of Regulatory Affairs professionals, fostering a culture of compliance, and preparing management reports for senior leadership. A minimum of 15 years of experience in regulatory affairs in the pharmaceutical industry, along with a Master's degree in Pharmaceutics or Regulatory Affairs, is required.
Required Qualifications
- Minimum 15-Years of Experience in regulatory affairs with OSD/Parenteral including conventional as well as complex dosage forms in generic space (ANDA/MAA/ANDS) and/or NDA/505(b)(2).
- M.Pharma in Pharmaceutics or Regulatory Affairs.
Desired Qualifications
- Any additional degree is preferred.
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