Director Regulatory Affairs

Director Regulatory Affairs / Senior Director Regulatory Affairs

Our main goal is to develop drugs against cancer. The first drug candidate will enter clinical development in 2021 and we are in the process of expanding our pipeline to deliver several development candidates and start new clinical programs through the next few years.

The function holder will act as the global regulatory lead on development programs, providing regulatory guidance and oversight. He/ She will be responsible for management of all regulatory activities, including management of regulatory service providers. He/ She will be responsible for the development and execution of regulatory strategies including submission strategies, to ensure the expeditious review and approval of clinical trials. Further the function holder will manage and coordinate the preparation of all required regulatory documentation. He/She leads, influences, and defends the regulatory position in regulatory agency interactions and acts as regulatory Subject Matter Expert when reviewing clinical documents, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) throughout development.

Duties & Responsibilities:

• Carry out a full review of current status of all regulatory matters and support the Board of Directors to define the company’s future regulatory strategy.
• Act as the regulatory representative on and provide strategic regulatory guidance to project teams.
• Management of, and collaboration with, regulatory service providers for regulatory submissions.
• Lead the planning and preparation of all preclinical and clinical regulatory submissions (e.g., INDs, CTAs, Orphan Drug Applications, Pediatric Investigational Plans, Scientific Advice requests, etc.)
• Establish and manage regulatory timelines.
• Responsible for submitting high quality regulatory documents required to obtain successful outcomes.
• Prepare meeting requests and briefing documents; make sure a team is well prepared for meetings/teleconferences with regulatory agencies.
• Coordinate and prepare responses to Regulatory Agency requests
• Prepare regulatory development plans for all projects.
• Develop and maintain regulatory knowledge.
• Serve as an interface with CMC, nonclinical and clinical research personnel and help keep them informed of new regulations, standards, policies, and guidance issued by regulatory authorities.
• Communicate the company’s position to internal and external stakeholders.
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.