KBD Talent Forge
Website:
kbdtalentforge.com
Job details:
Global Regulatory Strategy Manager is responsible for developing and implementing regulatory strategies that support global drug development, approvals, and lifecycle management. The role ensures compliance with international regulatory requirements while accelerating market access for pharmaceutical products.
This position works closely with R&D, clinical development, quality, and commercial teams to ensure regulatory strategies align with global business Develop and execute global regulatory strategies for pharmaceutical products across key markets.
- Lead regulatory submissions including IND, NDA, BLA, and MAA dossiers.
- Coordinate with international regulatory agencies such as U.S. Food and Drug Administration, European Medicines Agency, and Central Drugs Standard Control Organization.
- Provide regulatory guidance during drug development and clinical trials.
- Manage regulatory documentation and ensure compliance with global standards.
- Monitor changing regulatory policies and assess their impact on product development.
- Collaborate with cross-functional teams to support product registration and lifecycle management.
- Support regulatory inspections and Masters or PhD in Pharmacy, Life Sciences, or Biotechnology.
- MBA is an added advantage
- 6 - 12 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of global regulatory guidelines and submission processes.
Key Skills
- Global regulatory strategy development
- Drug approval and submission management
- Regulatory compliance and documentation
(ref:iimjobs.com)
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