Senior Regulatory Affairs Director (Vaccines & Immune Therapies)

AstraZeneca•Gaithersburg, MD

7d•Hybrid

About The Position

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 vaccines and immune 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 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 s uccessful 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 a bility to think strategically and critically evaluate risks to regulatory activities.
Ability to work strategically within a complex, business-critical and high-profile development program.

Nice To Haves

Experience in Infectious Diseases is strongly preferred

Responsibilities

Effectively lead or deputise for T h erap e utic Area (T A ) VP/Regional VP in senior-level interactions internally or externally , including contributions to in ternal 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

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Competitive salary and benefits package on offer
The annual base salary for this position ranges from $ 211,581.60 - 317,372.40 . 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.

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