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.

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.

DNA Life Sciences