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Regulatory Affairs Director

2 months ago

Reston, Virginia, United States DNA Life Sciences Full time

About the Role:

We are seeking a highly skilled Regulatory Affairs Director to join our team at DNA Life Sciences. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines, and for developing and implementing strategies to support the successful launch and lifecycle management of our products.

Key Responsibilities:

  • Collaborate with internal teams to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, and other relevant applications.
  • Ensure adherence to FDA and other health authority specifications and timelines, including submissions, correspondence, approvals, and accurate and organized records.
  • Manage third-party vendor partner performance and workload to support regulatory operations and publishing.
  • Provide project management support for regulatory projects, including defining project objectives, developing project plans, allocating resources, and monitoring progress.
  • Serve as a primary contact and maintain effective relationships with regulatory experts, including the FDA, EMA, and other regulatory agencies.
  • Develop and implement standard operating procedures (SOPs), best practices, and quality control measures to ensure compliance with regulatory standards.

Requirements:

  • Bachelor's degree in life sciences, pharmacy, or a related field with a minimum of 7-10 years of experience in oncology regulatory affairs within the biopharmaceutical industry.
  • Experience with global regulatory requirements and guidelines, from preclinical and clinical stages, including FDA, EMA, IHC, and drug laws, regulations, guidelines, and lifecycle management.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams, external partners, and regulatory authorities.
  • Experience in managing regulatory inspections, audits, and interactions with regulatory agencies, including direct contact with regulatory agencies.
  • Experience with executing regulatory strategies for complex products or therapies, including regulatory interactions, submissions, filings, and approvals.