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Hiring companyParexel
Verified today
Senior Manager, Regulatory Affairs
Mumbai,India Full-time Remote
About the role
Regulatory Affairs team at Parexel leads the development and implementation of regulatory strategies for clinical trials. The Senior Manager provides leadership, acts as SME for EU Clinical Trials Regulation, and drives capability building across a distributed team. Remote work from Bengaluru or Mumbai, India, with full-time employment.
What you’ll do
- Provide strategic regulatory guidance as SME for EU CTR
- Lead and develop a remote regulatory affairs team
- Drive capability building through coaching and training
- Support regulatory audits and inspections
- Develop and maintain SOPs
What you’ll bring
- Extensive experience in EU Clinical Trials Regulation (EU CTR)
- Leadership of consulting teams
- Strategic regulatory guidance
Skills
Regulatory AffairsEU Clinical Trials RegulationStakeholder ManagementTeam LeadershipProcess Improvement