Associate Director/Director for Regulatory Affairs

Required qualifications

• Education: Advanced degree in life sciences, pharmacy, or a related field.
• Experience: 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Proven track record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA.
• Experience in regulatory strategy planning for generic drugs and combination products.

• Strong knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions.

• Exceptional project management skills with the ability to manage multiple priorities and deadlines.

• Strong analytical and problem-solving skills with a proactive and solutions-oriented mindset.

• Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies.

1. 1Regulatory Strategy Development:
   • Develop and implement comprehensive regulatory strategies to support the development phase according to the current FDA guidances and recent trends.
   • Provide regulatory leadership during all phases of product development, including preclinical, clinical, and manufacturing stages, ensuring alignment with FDA standards and guidelines.
   • Assess and mitigate regulatory risks, ensuring anticipated challenges are addressed proactively.
   • Regulatory Submissions and Approvals: Oversee the preparation, submission, and management of high-quality regulatory documentation, including INDs, NDAs, ANDAs, and amendments to the FDA.
   • Plan and execute submission timelines to ensure timely filings and approvals within project deadlines.
   • Collaborate with cross-functional teams, including R&D , Clinical Affairs, Quality, and Manufacturing, to compile, review, and finalize submission packages.
   • Communication and Liaison with FDA: Serve as the primary point of contact with the FDA for assigned development programs, ensuring a professional and transparent relationship. Coordinate and facilitate meetings with the FDA, including Pre-IND, End-of-Phase, and Pre-NDA meetings, PDEV -meeting for ANDAs and Control Correspondences to ensure alignment with regulatory expectations.
   • Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum.
   • Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation, advertising, promotional materials, and post-marketing surveillance.
   • Support the coordination of Risk Evaluation and Mitigation Strategies (REMS) and ensure compliance with post-approval regulatory commitments.

1. 2Regulatory Affairs Expertise and Leadership:
   • Stay current with evolving FDA regulations, guidances, and industry trends to ensure compliance and improve internal regulatory processes.
   • Provide mentorship, training, and guidance to junior regulatory staff and help cultivate a high-performing regulatory team.
   • Represent the Regulatory Affairs function in internal and external meetings, providing strategic insights to support business and development goals.