Senior Director, Global Regulatory Strategy

AstraZeneca•Boston, MA

1d•Hybrid

About The Position

At Alexion, Rare Disease, everything we do is underpinned by our dedication to being a Great Place to Work. Put simply, our people are our greatest asset. We know that with a talented, brave and diverse team that believes in making a meaningful impact for people living with rare diseases, every day – incredible things happen. At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation of global regulatory strategy for complex, high-visibility rare disease programs. In addition to Global Regulatory Lead (GRL) responsibilities, the Sr RAD may also serve as regional regulatory lead. The Sr RAD will provide strategic and tactical leadership across regulatory and stakeholder functions with the objective of delivering according to regional and global business objectives for assigned programs. The individual will also ensure clear communication and constructive relationships with business partners and representatives of regulatory authorities.

Requirements

Advanced degree in a science field and 10+ years of relevant experience.
Deep understanding of global regulatory science and its integration with program strategy.
Extensive experience across drug/biologic development, including high profile, complex or novel programs.
Proven leadership of regulatory and cross-functional teams and strong stakeholder management.
Ability to build relationships and collabore effectively at all levels in a global, matrixed organization.
Broad pharmaceutical industry experience and a track record of providing strategic regulatory advice from preclinical through post-approval.
Ability to think strategically and critically and to assess regulatory risks.
Experience leading major Health Authority interactions.
Successful leadership of at least one global approval, including leading response team and labeling negotiations.
Excellent oral, written, and presentation skills with the ability to influence across functions and geographies.
Strong organizational skills and the ability to work in a fast-paced, hands-on environment.
Flexible and proactive, able to manage multiple projects and adapt to changing priorities.
Up-to-date knowledgeable of new and emerging regulations and guidances.
Understanding of relevant GxPs and how to locate and interpret regulatory information.
Experience with regulatory documentation systems (e.g., Veeva)

Nice To Haves

Multi-regional experience (e.g. US, EU, Japan, Emerging Markets).
Prior experience in rare disease, oncology, or cell and gene therapy.
Experience with due diligence activities and alliance partnerships.
Experience developing talent through coaching or mentorship.
Contributions to non-project business initiatives (e.g. portfolio or cross-functional effort).

Responsibilities

Develop and execute global regulatory strategy for high-complexity rare disease assets from early development through global submission and approval.
May serve in a dual role as GRL and regional lead.
As a core member of the Global Product Team, design strategies that enable an efficient path to approval and competitive labeling, aligned with product attributes and the needs of the business, markets and patients.
Contribute to governance presentations.
Lead regulatory strategy for all health authority interactions, responses to information requests, expedited pathway designations.
Drive cross-functional preparation of major submissions (e.g., initial IND/CTA, NDA/BLA/MAA) in collaboration with regional regulatory leads.
Lead the Global Regulatory Strategy Team (GRST) for assigned indication(s) and asset(s) within the rare disease unit.
Guide cross-functional teams through complex regulatory landscapes, leveraging expertise to craft and deliver compelling strategies.
Communicate priorities and goals to build alignment.
Independently resolve complex issues and manage regulatory risks within project teams.
Partner with senior leaders across clinical, commercial, medical affairs, and other functions to provide portfolio or therapeutic area regulatory insight and broader development expertise.
Support regulatory policy priorities based on Alexion and AstraZeneca’s knowledge and expertise.
Champion innovative regulatory approaches and present strategies and plans to leadership and cross-functional teams.
Lead and contribute to non-project functional or cross-functional initiatives.; drive development of novel regulatory tools and technology.
Demonstrate strong strategic, leadership, and collaboration skills.
Coach and provide performance feedback to regulatory and cross-functional colleagues, fostering innovation to drive effective product development.
Support business development activities as needed, including regulatory due diligence, gap assessments, and resource planning.
Model exemplary behavior, ethics, and transparency within the enterprise and in interaction with Health Authorities and other external stakeholders.