Senior Regulatory Affairs Director- Infectious Diseases
About The Position
AstraZeneca’s Senior Regulatory Affairs Director (SRAD) leads global regulatory strategy for complex infectious disease products, with the goal of securing rapid approvals that meet business, market, and patient needs. The role provides strategic leadership grounded in expertise in global regulatory science, drug development processes, and regulatory strategies for high-profile programs. Disease-area familiarity is important for influencing cross-functional discussions with Global Product Teams and other stakeholders. The SRAD may serve as Global Regulatory Lead for a product group and may also act as a regional lead, depending on location. The position guides development programs from early and late-stage development through commercialization strategy, and involves interaction with Global Health Authorities. It also includes leadership of regulatory teams and cross-functional initiatives.
Requirements
- Master’s degree in a science-related field.
- At least 10 years of experience, or equivalent, in regulatory drug development, including successful contribution to a major global regulatory approval.
- Previous experience leading major Health Authority interactions, such as FDA advisory committee meetings, oral explanations, scientific advice, Pre-NDA/BLA, or EOP2 meetings.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business-critical, high-profile development program.
Nice To Haves
- An advanced degree.
- Experience in Infectious Diseases.
Responsibilities
- Lead or deputise for the Therapeutic Area Vice President or Regional Vice President in senior internal or external interactions, including contributions to internal governance.
- Develop and implement product regulatory strategies to support rapid approval and advantageous labeling.
- Lead 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, incorporate regional regulatory needs into the Global Regulatory Strategy, and ensure its execution.
- Deliver regulatory milestones, assess probabilities of regulatory success, and implement risk mitigation measures.
- Partner with marketing and regional regulatory affairs staff to 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 and clear documentation of discussions.
- Lead development and updates of Regulatory Strategy Documents for complex projects.
- Monitor changes in the regulatory environment and advise Global Product Teams accordingly.
- Provide regulatory leadership in product in-licensing and due diligence review, divestment, and withdrawal.
- Lead complex cross-functional projects designed to improve efficiencies and simplification.
Benefits
- Short-term incentive bonus opportunity.
- Eligibility to participate in an equity-based long-term incentive program for salaried roles.
- Qualified retirement program (401(k) plan).
- Paid vacation and holidays.
- Paid leaves.
- Medical, prescription drug, dental, and vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
