Vice President, Head of Regulatory Science and Execution
Alexion

This is what you will do:

Strategic, experienced and with a strong delivery track record, the Vice President, Head of Regulatory Science and Execution is a key Leader of the Regulatory Affairs team and a critical contributor to the R&D and Commercial deliverables of Alexion, AZ rare disease unit. Accountable for the regulatory objectives and activities in the US and EU, across the pipeline and portfolio lifecycles, this person is expected to lead and oversee performance of the US and EU Regulatory Affairs team, while positively influencing the regulatory environment for rare diseases' regulatory science.

You will be responsible for:

• Accountable for the delivery of the R&D pipeline and the commercial portfolio regulatory objectives in the US and EU, in view of global strategies agreed across the Regulatory Affairs team;
• Serves as the key reviewer and advisor for US and EU regualtory strategies developed and executed by Regulatory Affairs Directors and Leads.
• Be accountable for ensuring ideal registration outcomes and regulatory compliance of the R&D pipeline and commercial portfolio in the US and EU, in order to best serve patients with rare diseases;
• Oversee and manage effectively the the US and EU Regulatory Affairs team, ensuring teams are allocated and work towards business priorities with adequate resources, time and intent;
• Serve as an influential and well-respected spokesperson for negotiations with health authorities like the US Food and Drug Administration (FDA) and European Medicinies Agency (EMA) potentially delegating such responsibilities to other staff in the team as needed/relevant;
• Accountable to establish good working relationships with authorities such as the US FDA, EMA and other relevant stakeholders that positively contribute to the regulatory environment, including non-governmental organizations, trade associations, amongst others;
• Oversees, actively engages and supports Regulatory Policy activities, shaping its priorities with contribution from other RA Leaders, Corporate Affairs and other stakeholders;
• Be an active member of the Regulatory Affairs Leadership Team (RALT) and drive collaborative efforts to address global challenges in the team;
• Establish and maintain strong collaboration with internal and external stakeholders that critically contribute to the business, including but not limited to commercial teams (notably to support launch efforts and regulatory aspects), advertising and promotional compliance teams (notably to support effective compliance and collaboration), safety teams (notably to support REMS and controlled distribution) and other as applicable;
• Works collaboratively with other regions and with the intent to ensure alignment on the implementation of global regulatory strategies, including geographic expansion efforts relying on the US and EU outcomes;
• Recruit skilled and experienced Regulatory staff, ensuring it prioritizes development to effectively face the challenges the pipeline and portfolio present to business;
• Might engage in confidential due diligence efforts to support the regulatory impact assessment and evaluation as needed.
• Is expected to serve as a true Alexion Enterprise Leader, going beyond his/her remit to partner, collaborate, risk-mitigate and ensure the success for the Enterprise as a whole.

You will need to have:

Qualifications

• 15+ years of pharmaceutical and/or biotechnology industry experience with Leadership responsibilities, including 5+ years Experience leading US EU or Global (including US) Regulatory teams.
• Experience in R&D and/or commercial organizations in the field of rare diseases strongly desired.
• Biologics and advanced therapies/regenerative medicine experience is strongly desired.
• Experience in leading global, non-US team is a plus.
• Extensive experience and track-record in successful regulatory outcomes in the US and EU, ideally managing complex regulatory challenges and negotiations with the US FDA and EMA.

Education

• Advanced degree in a relevant life sciences area (e.g. Medicine, Pharmacy) or other relevant scientific area is necessary. A Doctoral (PhD) or Medical Degree (MD) is a plus.

Competences

• Strong management, interpersonal and communication skills required, together with the ability to deal effectively with a variety of staff and Leadership across the Enterprise;
• Strong leadership skills, negotiation, and collaboration abilities.
• Proven ability to succeed in a fast-paced environment.
• Excellent verbal and written Corporate communication skills in English, knowledge of other languages a plus.

Date Posted
29-Apr-2024

Closing Date
30-Jun-2024Alexion 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. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.