Regulatory Affairs Director, Global Regulatory Strategy

Regulatory Affairs Director, Global Regulatory Strategy

The Regulatory Affairs Director, Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead cross-regulatory teams and be accountable to provide key regulatory input to Global Program and / or Medicine Teams deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for :

• Accountable to develop and oversee global regulatory strategies, in the defined therapeutic area or portfolio.
• Providing regulatory strategic oversight for products and / or projects in the relevant therapeutic areas / portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
• Leading and supporting staff in preparation for regulatory authority meetings and providing input to submission strategy and other critical regulatory documents. May represent Alexion as point contact with relevant Health Authorities and / or lead interactions with such authorities or other relevant external stakeholders.
• Providing input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural / operational issues as they arise.
• Actively collaborating with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.
• Actively being up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise.
• Ensuring exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities and other external stakeholders.

You will need to have :

Education :

Competences :

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!

Competitive salary and benefits package on offer.

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.

The annual base salary for this position ranges from $186,232.80 - 279,349.20. 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.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com .