Apply on Employer Site

AstraZeneca · 5 hours ago

Senior Regulatory Affairs Director (Vaccines & Immune Therapies)

Gaithersburg, MD

Full-time

Hybrid

Director/Executive

$212K/yr - $317K/yr

10+ years exp

AstraZeneca is committed to developing transformative vaccines and antibodies to improve public health. The Senior Regulatory Affairs Director will lead global regulatory strategies for complex products, ensuring rapid approval and effective cross-functional collaboration.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Effectively lead or deputise for Therapeutic Area (TA) VP/Regional VP in senior-level interactions internally or externally, including contributions to internal governance

Develop and implement regulatory strategies for products, ensuring rapid approval with advantageous labeling

Lead the planning and construction of global dossiers and core prescribing information

Conduct regulatory risk planning and mitigation

Serve as the single point of contact and Global Regulatory Affairs representative on Product Development Teams

Lead the Global Regulatory Sub-team to ensure regional regulatory needs are incorporated into the Global Regulatory Strategy and ensure execution on strategy

Deliver all regulatory milestones, assess regulatory success probabilities, and implement risk mitigation measures

Partner with marketing and regional regulatory affairs staff to help shape the environment and Health Authorities' views on relevant topics

Lead regulatory staff on complex projects to ensure prioritized objectives are delivered on time and with quality

Ensure effective regulatory representation at health authority meetings with clear documentation of discussions

Lead the development and updates of the Regulatory Strategy Document for complex projects

Monitor changes in the regulatory environment and advise Global Product Teams accordingly

Provide regulatory leadership in product in-license/due diligence review, divestment, and withdrawal

Lead complex projects designed to improve efficiencies and simplification, spanning cross functional areas

Qualification

Regulatory drug developmentGlobal regulatory strategyHealth Authority interactionsInfectious Diseases experienceLeadership experienceProgram managementRisk evaluationStrategic thinking

Required

Advanced degree in a science-related field and/or other appropriate knowledge/experience

At least 10 years experience or equivalent of regulatory drug development including successful contribution to a major regulatory approval at a global level

Must have previous experience in leading Major Health Authority interactions (e.g., FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.)

Proven leadership and program management experience, as well as the ability to think strategically and critically evaluate risks to regulatory activities

Ability to work strategically within a complex, business-critical and high-profile development program

Preferred

Experience in Infectious Diseases is strongly preferred

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

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees