Global Regulatory Strategy Director - Oncology

Regulatory Jobs; Cambridge (MA); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation and holidays

Paid leaves

Health benefits including medical, Rx,

dental and vision coverage

Job summary

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.

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.

Skills

Strategic thinking

Strategic influencing

Risk evaluation

Innovation

Leadership

Communication skills

Education

Bachelor's degree in a science related field

Job description

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.