Senior Regulatory Affairs Director- Infectious Diseases

AstraZeneca plc; Gaithersburg (MD); Hybrid; USD 218,000 - 327,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits

Job summary

AstraZeneca plc is seeking a Senior Regulatory Affairs Director to oversee global regulatory strategy for Infectious Diseases programs. This role leads cross-functional teams, guides regulatory submissions, and interacts with health authorities to secure timely approvals.

Flexible hybrid work is available with on-site collaboration. The SRAD drives strategic decision-making, manages complex global dossiers, and collaborates with GPTs to align regulatory plans with development milestones and

Qualifications

• Master’s degree in a science-related field or equivalent experience.
• 10+ years in regulatory drug development with global approvals.
• Infectious Diseases experience preferred.
• Leading major Health Authority interactions (FDA etc.).
• Demonstrated leadership and program management in complex programs.

Responsibilities

• Lead or deputise for TA VP/Regional VP in senior-level interactions.
• Develop and implement regulatory strategies to achieve rapid approvals.
• Lead planning of global dossiers and core prescribing information.
• Conduct regulatory risk planning and mitigation.
• Serve as Global Regulatory Affairs representative on Product Development Teams.
• Ensure regional regulatory needs are incorporated into Global Strategy.
• Deliver regulatory milestones and manage risk mitigation measures.
• Collaborate with marketing and regional staff to shape authority views.
• Oversee regulatory staff on complex projects to meet objectives.
• Represent regulatory discussions at health authority meetings with clear documentation.
• Develop and update of Regulatory Strategy Document for complex projects.

Skills

Regulatory leadership

Strategic thinking

Program management

Cross-functional collaboration

Global health authority interactions

Education

Master’s degree

Advanced degree preferred

Job description

AstraZeneca - Infectious Diseases

At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in infectious disease therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people.

Role

The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex products. They aim to secure rapid approval that meets business, market, and patient needs. The SRAD offers strategic leadership and has expertise in global regulatory science, drug development processes, and strategies for high-profile programs. Familiarity with the disease area is essential to influence cross-functional discussions with Global Product Teams (GPT) and stakeholders. They can serve as the Global Regulatory Lead (GRL) for a product group and also act as a regional lead based on their location.

Your strategic leadership skills and deep understanding of global regulatory science from early to late-stage development into commercialization strategy will be crucial in influencing cross-functional discussions and guiding high-profile development programs, as well as interacting with Global Health Authorities. Are you prepared to take on the Global Regulatory Lead role and drive innovative strategies for regulatory success?

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.

Qualifications

• Master’s degree in a science-related field required. An advanced degree is preferred; equivalent relevant knowledge and experience may also be considered.
• At least 10 years experience or equivalent of regulatory drug development including successful contribution to a major regulatory approval at a global level.
• Experience in Infectious Diseases is strongly preferred.
• 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.

Why AstraZeneca

Here, regulatory leaders help transform pioneering science into therapies that reach patients faster—by driving innovative approaches, smart risk-taking, and disciplined execution. You will work across a rich pipeline with colleagues who value curiosity and kindness alongside ambition, bringing unexpected teams together to unlock knowledge and sharpen strategy.

Our globally connected community blends cutting-edge technology with deep disease expertise, embraces data and automation to reduce cycle times, and thrives on collaboration that turns complex challenges into concrete outcomes for patients. Your ideas will be heard, your growth supported, and your impact visible in every milestone we achieve.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.

The annual base salary for this position ranges from $218,058.40 - $327,087.60 USD Annual. 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). Benefits offered included 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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. 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 05-Nov-2026

Closing Date 30-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.