Consultant at Domnic Lewis International
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Director - Regulatory Affairs - Pharma (12-18 yrs)
We are having job opportunity with Leading Pharma MNC "Director Regulatory Affairs (Rare Disease) based out in Bangalore.
- Lead and develop the regulatory team, ensuring continuous employee growth and portfolio planning.
- Set direction for projects and portfolio strategy, actively participating in cross-functional matrix teams with other senior stakeholders within and beyond Regulatory Affairs.
- Accountable for efficient people processes and development, including talent management and succession planning.
- Oversee daily operations, adhering to company-wide policies, procedures, and programs.
- Provide strategic guidance for authority interactions and regulatory approval strategies for the product portfolio.
- Utilize creativity and out-of-the-box thinking to identify and assess regulatory opportunities.
- Foster a strong network of regulatory professionals within HQ and beyond, including affiliates and regions.
- Champion diversity, equity, and inclusion within the team actively.
- Demonstrate excellent communication skills (written, oral, and presentation) and strong business acumen.
- Exhibit political and strategic agility in navigating complex regulatory landscapes.
- 5+ years of proven leadership experience managing teams of 8+ employees.
- 12+ years of relevant experience in GxP (Good X Practice) in Medical Affairs, Regulatory Affairs, or Pharmacovigilance.
- Thorough understanding of regulatory dossiers and requirements (MAA/NDA/BLA/CTA/INDs, etc.).
- Demonstrated ability to think creatively and beyond guidelines to identify opportunities.
- Strong track record of developing and leading high-performing individuals and teams.
- Effective communication skills and ability to collaborate with cross-functional stakeholders.
- Possess strong business acumen and strategic thinking abilities.
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