Director - Regulatory Affairs - Pharma

We are having job opportunity with Leading Pharma MNC "Director Regulatory Affairs (Rare Disease) based out in Bangalore.

Key Responsibilities:

- 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.

Qualifications:

- 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.