Regulatory Affairs Director

AstraZeneca • Cambridge, MA

1d • $186,233 - $279,349 • Hybrid

About The Position

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership for the development, commercialization, and life-cycle management of assigned oncology products. The role serves as the global regulatory lead on early-stage projects or specific indications within larger programs, and/or as a regional regulatory lead. The RAD plays a substantial role in shaping clinical strategy and influencing health authorities to improve outcomes.

The Director leads cross-functional regulatory work, major submissions, and health authority engagement, and develops strategies intended to secure timely approval with competitive labeling. The role also leads a Global Regulatory Strategy Team, mentors team members, manages regulatory milestones and risks, and oversees regulatory strategy documents, target product labeling, global dossiers, and core prescribing information. The position partners with marketing companies and regional regulatory affairs staff on emerging guidance and product maintenance, supply, and compliance activities.

The role is based on a flexible approach that includes face-to-face work in offices three days a week. The position offers a competitive salary and benefits package.

Requirements

• Bachelor's degree in a science-related field.
• 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.
• Demonstrated experience in regulatory drug development or equivalent, including experience with major health authority interactions.
• Demonstrated strategic thinking, strategic influencing, risk evaluation, innovation, initiative, and leadership competencies.
• Excellent oral and written communication skills.

Nice To Haves

• Advanced degree.
• Experience in the development or application of radio-conjugates.
• Oncology experience with small molecules and biologics.
• Prior experience with Phase 3 design, including end-of-Phase-2 health authority interactions.
• Contribution to a regulatory approval, including leading a response team and labeling negotiations.
• Knowledge and understanding of drug-development principles such as benefit/risk profile, dose selection, or statistical design.
• Broad pharmaceutical business experience and prior experience in several areas within regulatory affairs.
• Ability to work strategically within a business-critical, high-profile development program.
• Critical thinking on current global regulatory science questions and a good understanding of the corresponding scientific and clinical components.

Responsibilities

• Lead cross-functional teams in major regulatory submissions, including NDA, BLA, IND, and CTA submissions; health authority interactions; label discussions; and approval efforts.
• Develop and implement regional or global program strategy aimed at rapid approval and competitive labeling informed by the business, markets, and patients.
• Develop health authority engagement strategies and interaction plans; drive preparation of strategy- and science-focused briefing documents; lead meeting rehearsals; and moderate health authority meetings.
• Lead a Global Regulatory Strategy Team (GRST) comprising regional contributors, emerging markets, RA CMC, Labeling, and submission and execution team members; mentor members and provide performance feedback.
• Deliver regulatory milestones, assess risks and mitigations, evaluate emerging data and probability of success, and lead preparation of regulatory strategy documents and target product labeling.
• Own 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 country marketing companies and regional regulatory affairs staff to influence developing views and guidance.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles, or receive a retirement contribution for hourly roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Director