Director of Regulatory Affairs

Responsibilities:

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

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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 (including FDA, EMA, IHC), from preclinical, and clinical stages. Expertise and knowledge of 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.