Director Regulatory Affairs Strategy

Are You a Strategically Focused Regulatory Professional?

Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life-changing Respiratory & Immunology medicines to patients? If you are, please read on!

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Respiratory & Immunology – Regulatory Science and Strategy

AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory and Immunology (R&I), two of our major therapy areas. To meet the increasing demand for regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists. With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

The Role: Regulatory Affairs Director

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization, and life cycle management of assigned products. The RAD serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role in crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

What You’ll Do

• Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
• Develop and implement the program’s regional or global strategy to deliver rapid approval with competitive labeling identified by the business, markets, and patients.
• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals, and moderate the meeting itself.
• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from regions, emerging markets, RA CMC, labeling, and submission execution teams. Mentor and provide performance feedback to members of your GRST.
• Deliver regulatory milestones on your team, including risk assessment, emerging data analysis, and success probability. Lead preparation of the regulatory strategy document and target product labeling.
• Negotiate with health authorities and deliver key regulatory documents.
• Plan and construct the global dossier and core prescribing information, including product maintenance, supply, and compliance activities.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views and guidance.

Essential Qualifications

• Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.
• 5+ years of regulatory experience in the pharmaceutical industry in early and late development, with a significant track record in global strategies.
• Strong knowledge of drug development and regulatory policy, coupled with excellent scientific and business judgment.
• Successful track record in registering and overseeing regulatory strategies for assets.
• Proven successful leadership and project management experience.
• Broad background of experience working in several groups in regulatory affairs or experience at a health authority.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance.

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Here, you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society. We champion an inclusive culture, diversity, and collaboration while committing to lifelong learning and development. Join us on this exciting journey to pioneer the future of healthcare.

Competitive Salary and Benefits Package

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 three days a week.

The annual base salary for this position ranges from $173,600 to $260,401. 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 include 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, the 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.

Commitment to Diversity

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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