Senior Regulatory Affairs Director

AstraZeneca • Gaithersburg, MD

4d • $218,058 - $327,088

About The Position

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges with integrity. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Senior Regulatory Affairs Director, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. R&D Oncology drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

Requirements

• A Bachelor’s degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• 10+ years experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Deep understanding of global regulatory science and integration with program strategy.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Proven experience leading regulatory, cross-functional teams, and stakeholder management.
• Successful leadership of at least one global regulatory marketing approval as GRL across major regions (US and EU) including leading response team and labeling negotiations.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Previous experience in leading major Health Authority interactions.
• Excellent oral, written, and presentation skills.
• Strong organisational skills.
• Ability to work in a fast-paced environment in a hands-on fashion.
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.

Nice To Haves

• Master's or PhD degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• Experience in the development or application of radio-conjugates would be highly advantageous.
• Experience with FDA advisory committee and CHMP oral explanation.
• Experience working on due diligence activities and in a business alliance environment.
• Experience in leading and growing people through coaching or mentorship.
• Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).
• Experience in Oncology (small molecules and biologics) is preferred.

Responsibilities

• Lead the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
• Ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
• Show strategic leadership skills, and a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Lead the planning and construction of the global dossier and core prescribing information.
• Conduct regulatory risk planning and mitigation.
• Lead the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement.
• Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
• Accountable for product maintenance, supply and compliance activities associated with marketed brands.
• Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
• Partner with marketing company and regional regulatory affairs staff to influence developing views/guidance.
• Lead the regulatory staff working, provide leadership and participate in skill-development, coaching, and performance feedback.
• May line manage, develop, and coach Regulatory Affairs Directors (RAD) and/or Associate Regulatory Affairs Directors (ARAD) team members, and maintain and contribute to recruitment of staff to oversee team accountabilities.
• May be accountable for leadership of regulatory operational activities from planning to submission of regulatory applications and HA interactions, providing regulatory expertise and advice on procedural and documentation requirements to product teams and execution submission delivery plans across all regions.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• Retirement contribution
• Commission payment eligibility
• 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