Regulatory Affairs Director

Regulatory Toolkit; Cambridge (MA); Sur place; USD 186 000 - 279 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Paid vacation and holidays

Paid leaves

Health benefits including medical, Rx,

dental and vision coverage

Résumé du poste

AstraZeneca in Cambridge, MA is seeking a Regulatory Affairs Director to provide strategic and operational regulatory leadership across oncology programs. The role spans global/regional leadership, drafting strategy, and engagement with health authorities.

The RAD will lead cross-functional teams, shape global regulatory strategy, mentor a GRST, manage milestones, and negotiate with authorities to drive rapid, well-labeled approvals.

Qualifications

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

Responsabilités

• 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.

Connaissances

Strategic thinking

Strategic influencing

Risk evaluation

Innovation

Leadership

Communication skills

Formation

Bachelor's degree in a science related field

Description du poste

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?

At AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe.

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

What you'll do:

• 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.

Essential skills & experience:

• Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.

• A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.

• Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.

• Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.

Preferred Qualifications:

• Advanced degree preferred.

• Experience in the development or application of radio-conjugates would be highly advantageous.

• Experience in Oncology (small molecules & biologics) 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 and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.

• Ability to work strategically within a business critical and high-profile development program.

• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

The annual base salary for this position ranges from $186,232.80 - 279,349.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).

• a qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

27-Oct-2026

Closing Date

14-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.