Domnic Lewis has been mandated to hire for one of our Prestigious Pharma MNC Client.
Role- Director Regulatory Affairs
Location - Delhi or Bangalore
Experience- 15+ Yrs
Direct Regulatory Strategies:
- Develop regulatory strategies to achieve rapid and high-quality approvals, ensuring alignment with business objectives.
- Maintain in-depth knowledge of product portfolios, regulatory intelligence, and timelines to optimize submission strategies.
- Ensure local regulatory strategies align with global product strategies and priorities.
- Collaborate with stakeholders to optimize risk versus commercial benefits in submission strategies.
- Track regulatory approval status and implement corrective measures as needed.
Maintain Product Licenses:
- Oversee the status of all product licenses and manage changes effectively.
- Maintain comprehensive documentation and communicate changes promptly.
- Allocate resources for effective license maintenance.
Build and Lead Regulatory Team:
- Recruit, retain, and motivate a high-performing regulatory team.
- Define roles, responsibilities, and performance criteria; provide coaching and development opportunities.
- Foster cross-functional communication and collaboration.
- Ensure compliance across GXP areas and develop a compliance mindset within the team.
Provide Leadership:
- Establish a clear vision and objectives for the regulatory affairs department.
- Drive performance, decision-making, and accountability within the team.
- Promote a positive and innovative mindset, challenging the status quo for continuous improvement.
- Influence company decisions and cultivate a supportive work environment.
Shape Regulatory Environment:
- Collaborate with regulatory teams and other functions to engage key stakeholders.
- Build relationships with Regulatory Authorities and contribute to portfolio planning committees.
- Monitor regulatory changes and communicate implications to stakeholders.
Adherence to Ethics and Compliance:
- Uphold industry codes of conduct, ethical standards, and regulatory best practices.
- Ensure compliance with local legislation, global regulatory policies, and corporate governance.
- Oversee training on regulatory issues for other functions and ensure confidentiality of company information.
Issue Management:
- Provide regulatory guidance on product issues and collaborate with authorities for resolution.
- Coordinate cross-functional responses to regulatory issues.
Monitor Regulatory Environment:
- Stay informed about local and global regulatory changes and assess their impact on products.
- Analyze business and political environments to anticipate regulatory challenges.
Essential Requirements:
- 15+ years of experience in Bio-Pharmaceuticals, including Regulatory Affairs, with at least 3 years in middle-senior management.
- Bachelor's degree in medicine OR master's degree in Science/Pharmacy/Medicine OR Doctorate.
- Extensive experience in new drug approvals, clinical trials, pharmacovigilance, and biologics.
- Strong business acumen and up-to-date knowledge of regulatory developments.
- Experience in innovator/R&D driven pharmaceutical multinational corporations preferred.
- Previous team management experience is advantageous.
Key Functional Capabilities:
- Excellent scientific and regulatory knowledge.
- Strong communication and interpersonal skills.
- Effective planning and organizational abilities.
- Ability to foster strategic partnerships.
Interested candidates, drop their resume at [Confidential Information] OR call/message at 8459080422.
