Senior/Executive Director Regulatory Affairs

Title: Senior/Executive Director Regulatory Affairs

Summary: A growing immuno-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.

The S/E Director of Regulatory Affairs will be responsible for:

• Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teams
• Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks
• Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy
• Prepare and lead teams in regulatory meetings and interactions with notified bodies
• Lead the authoring and review of regulatory documents in a timely manner
• Lead department initiatives and assist in training and oversight of the RA team

Qualifications:

• 10+ years in Regulatory in biopharma industry or equivalent
• Extensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products and IVDs (IDE/IND/CTA/BLA/NDA)
• Ability to develop and implement regulatory strategies in the Oncology field
• Experience working with regulatory agencies and effectively move products through the development process
• Highly collaborative working style with the ability to work in cross-functional teams