Senior VP/Head of Regulatory Affairs

3 weeks ago

Newark, United States Leaman Life Sciences Full time

About Us: Our client is a pioneering leader in the development of innovative ophthalmic treatments and therapies. They are committed to advancing the field of ophthalmology through cutting-edge research, groundbreaking technology, and a dedication to improving patient outcomes worldwide.

Position Overview: As the Senior Vice President/Head of Regulatory Affairs, you will play a pivotal role in shaping the regulatory strategy and ensuring compliance for their portfolio of ophthalmic products. Reporting directly to the CEO, you will lead a talented the function of RA and collaborate closely with cross-functional teams to drive regulatory initiatives and secure approvals for their products in global markets.

Key Responsibilities:

  1. Regulatory Strategy Development: Develop and implement global regulatory strategies aligned with business objectives to support the successful development, registration, and commercialization of ophthalmic products.
  2. Regulatory Compliance: Ensure compliance with applicable regulatory requirements and guidelines, including FDA regulations, ICH guidelines, and international standards, throughout the product lifecycle.
  3. Regulatory Submissions: Oversee the preparation, submission, and management of regulatory submissions, including INDs, NDAs, BLAs, and marketing applications, to regulatory agencies worldwide.
  4. Agency Interactions: Serve as the primary point of contact for regulatory agencies, including the FDA and international regulatory authorities, and lead interactions, meetings, and negotiations to facilitate the approval process.
  5. Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Clinical Development, Quality Assurance, Medical Affairs, and Commercial, to integrate regulatory considerations into product development plans and ensure alignment across functions.
  6. Risk Management: Proactively identify regulatory risks and opportunities, develop risk mitigation strategies, and provide guidance to senior leadership on potential regulatory implications for business decisions.
  7. Team Leadership: Provide leadership, mentorship, and development opportunities for the regulatory affairs team, fostering a culture of excellence, innovation, and collaboration.
  8. Regulatory Intelligence: Stay abreast of emerging regulatory trends, developments, and best practices in the ophthalmic and pharmaceutical industries, and leverage insights to inform regulatory strategy and decision-making.

Qualifications:

  • Advanced degree in life sciences, pharmacy, or a related field; PhD or PharmD preferred.
  • 15+ years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry, with significant experience in ophthalmic product development.
  • Demonstrated expertise in developing and executing successful global regulatory strategies for ophthalmic products, including experience with FDA submissions and interactions.
  • Strong leadership skills with a proven track record of leading high-performing regulatory affairs teams and driving cross-functional collaboration.
  • Excellent communication, negotiation, and influencing skills, with the ability to effectively engage with internal stakeholders, external partners, and regulatory agencies.
  • Strategic mindset with the ability to think critically, anticipate challenges, and develop creative solutions to complex regulatory issues.
  • Thorough understanding of global regulatory requirements, guidelines, and standards applicable to ophthalmic products.

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