Regulatory Affairs Director

Role Summary

Regulatory Affairs Director 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 rapid approval with competitive labeling identified by the business, markets and patients.
• Craft the health authority engagement strategy and interaction plan, drive the briefing document focused on strategy and scientific content, lead meeting rehearsals and moderate the meeting.
• Lead a Global Regulatory Strategy Team (GRST) of regional, emerging markets, RA CMC, Labeling and submission/execution members; mentor GRST members.
• Deliver regulatory milestones with risk assessments, emerging data, and probability of success; prepare regulatory strategy document and target product labeling.
• Own negotiations with health authorities and initiate/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 and regional regulatory affairs staff to influence developing views/guidance.

Qualifications

• Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
• Solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
• Experience in regulatory drug development or equivalent, and with major health authority interactions.
• Strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.

Preferred Qualifications

• Advanced degree preferred.
• Experience in Hematology/Hemato-Oncology is preferred.
• Prior experience with phase 3 design including end of phase 2 health authority interactions.
• Contribution to a regulatory approval including leading response team and labeling negotiations.
• Knowledge of guiding principles in drug development such as benefit/risk, dose selection or statistical design.
• Broad background in pharmaceutical business and experience in several areas within regulatory affairs.
• Ability to work strategically within a business-critical and high-profile development program.
• Critical thinking on global regulatory science questions with understanding of clinical components.