Regulatory Affairs Director - Oncology

Role Summary

Regulatory Affairs Director - Oncology provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. Plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

Responsibilities

• Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
• Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.
• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
• Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.
• Own the negotiations with health authorities and initiate and deliver key regulatory documents.
• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Qualifications

• Required: Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
• Required: A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
• Required: Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
• Required: Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
• Preferred: Advanced degree.
• Preferred: Experience in Oncology (small molecules & biologics).
• Preferred: Prior experience with phase 3 design including end of phase 2 health authority interactions.
• Preferred: Contribution to a regulatory approval including leading response team and labeling negotiations.
• Preferred: Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
• Preferred: Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Preferred: Ability to work strategically within a business critical and high-profile development program.
• Preferred: Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

Skills

• Strategic regulatory planning
• Global/Regional regulatory leadership
• Health authority engagement
• Regulatory submissions and documentation
• Cross-functional team leadership
• Risk assessment and mitigation
• Negotiation with health authorities

Education

• Bachelor's degree in a science-related field (required)
• Advanced degree in a related field (preferred)