Senior Regulatory Affairs Director (Infectious Diseases)

AstraZeneca • Gaithersburg, MD

13d • Hybrid

About The Position

The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex products, aiming 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 commercialisation 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?

Requirements

• 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.
• 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.

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.

Benefits

• Competitive salary and benefits package
• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• Retirement contribution
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior