Regulatory Affairs Director

AstraZeneca; Kendall Square (MA); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

In-office 3 days a week

Job summary

AstraZeneca plc in Massachusetts is seeking a Regulatory Affairs Director (RAD) to provide strategic and operational regulatory leadership for oncology programs across development, commercialization, and lifecycle management.

You will lead global/regional regulatory strategy, engage health authorities, mentor the GRST, and drive major submissions and negotiations to achieve timely approvals.

Qualifications

• Bachelor’s degree in a science related field required.
• Strong regulatory strategy experience in drug development preferred.
• Excellent oral and written communication and leadership capabilities.

Responsibilities

• Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA) and health authority interactions.
• Develop and implement regional/global regulatory strategy to enable rapid approvals.
• Craft health authority engagement plans and prepare strategy-focused briefing documents.
• Lead a Global Regulatory Strategy Team (GRST) and mentor team members.
• Deliver regulatory milestones, assess risks and manage labeling strategy.
• Negotiate with health authorities and prepare key regulatory documents.
• Plan and construct global dossiers and core labeling information.

Skills

Strategic thinking

Leadership

Communication skills

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in science

Job description

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.

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 v

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.