Associate Director Regulatory Affairs

1 month ago


California, United States Life Science People Full time

A leading biotechnology firm specializing in dermatology research and development is looking for an Associate Director, Regulatory Affairs.

Position Summary:

The Associate Director of Regulatory Affairs will play a pivotal role in driving regulatory strategy and execution for our dermatology-focused biotech initiatives. Reporting to the Director of Regulatory Affairs, the successful candidate will lead regulatory activities related to the development, submission, and approval of dermatology products in compliance with global regulations and standards. This role requires a strategic thinker with a deep understanding of regulatory requirements, excellent communication skills, and the ability to collaborate effectively across multidisciplinary teams.

Key Responsibilities:

  1. Develop and implement regulatory strategies for dermatology product development programs, ensuring alignment with corporate objectives and regulatory requirements.
  2. Lead the preparation, review, and submission of regulatory documents, including INDs, CTAs, NDAs, BLAs, and other relevant submissions to global health authorities.
  3. Serve as the primary regulatory contact with health authorities and regulatory agencies, representing the company in meetings, discussions, and negotiations.
  4. Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including clinical development, manufacturing, quality assurance, and commercialization.
  5. Stay abreast of evolving regulations, guidelines, and industry trends related to dermatology products, and proactively assess their impact on product development activities.
  6. Collaborate with internal stakeholders to identify and mitigate regulatory risks, resolve issues, and ensure timely regulatory approvals.
  7. Contribute to the development and maintenance of regulatory processes, systems, and SOPs to support compliance and efficiency.
  8. Mentor and coach junior members of the regulatory affairs team, fostering their professional growth and development.

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