AstraZeneca · 20 hours ago
Regulatory Affairs Director
Gaithersburg, MD
Full-time
Hybrid
Lead/Staff, Director/Executive
$186K/yr - $279K/yr
3+ years expAstraZeneca is a global biopharmaceutical company committed to following the science and delivering life-changing medicines. The Regulatory Affairs Director will provide strategic and operational regulatory leadership for oncology products, ensuring efficient development and commercialization while engaging with health authorities.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
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 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
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
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