Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This role can be located in Switzerland or Sweden
Director, Central and Northern Europe Regulatory and Quality Affairs
This is what you will do:
This position is responsible for managing the local regulatory and quality activities for Alexion portfolio products in Central and Northern Europe. The Director, Central and Northern Europe Regulatory and Quality Affairs will ensure full compliance with all local regulations and corporate policies and act as the main contact person accountable for regulatory and quality activities in the local affiliate/marketing company, in respect to regulatory authorities. This individual will be responsible for overseeing the implementation and execution of the Corporate Quality System at the designated affiliate(s) within Alexion. Will act as a Local Regulator or Quality lead as necessary according to the needs of the team.
You will be responsible for:
- Lead local regulatory and quality teams to deliver on local responsibilities outlined in regulations, policies, and internal standards, aligned with business priorities.
- Oversee country affiliate input to regulatory strategies for portfolio products in development, as well as for the approved products in terms of life cycle management and commercial quality aspects.
- In collaboration with global regulatory leads (GRL), advise on clinical trial strategy where needed, and possible national scientific advice if relevant.
- Partner and coordinate with Commercial, Medical Affairs, Business Operations and Management (such as BUL, Medical Director, GM etc.) to define regulatory and quality priorities based on business opportunities and the affiliate’s business objectives.
- Accountable for all interactions with local Health authorities, including health authority meetings, inspections, and other regulatory compliance aspects.
- Responsible for local review, implementation and tracking of implementation of the risk management plans (RMP) and other post-authorization aspects for the Alexion products.
- Oversee local regulatory submissions in coordination with other Global Regulatory and Quality functions.
- Provides local regulatory environment intelligence and advises on expected regulatory hurdles and local specificities, while actively shaping the local regulatory environment for optimal outcomes.
- Oversees promotional and non-promotional reviews in collaboration with relevant stakeholders, and accountable for compliance with local legislation including transparency requirements on interaction with HCPs, internal compliance policies in collaboration with Medical Director/Compliance Champion – e.g., acts as local compliance committee coordinator.
- Oversee roll out and ongoing compliance to Alexion’s Global Quality and Compliance systems and associated procedures and standards.
- Assure appropriate escalations and notification to line management.
- Provide Quality leadership for territory expansion and new product introductions locally. This includes the maintenance and necessary updates to QAGs (Quality Agreements), initiation of audits, and support of required Quality documentation
- Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GxP requirements
- Oversee the review and implementation of Quality Improvement/remediation plans locally.
- Monitor GxP compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality Partner with local, regional, and global operational groups to foster a proactive approach to quality and compliance.
- Ensure adherence to Alexion procedures to vendor oversight, periodic KPI review and appropriate risk assessment and mitigation
- Manage and develop / mentor other members of the team.
You will need to have:
- Bachelor’s degree, preferably in life sciences. Advanced degree (PharmD or PhD) preferred.
- 10 years of hands-on Regulatory and/or Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
- Extensive knowledge in a broad range of pharmaceutical regulatory activities and Quality Systems.
- Strong Management & leadership ability
- Exceptional communication and interpersonal skills
- Ability to work globally in a matrix environment
- Ability to influence senior management, peers, and other colleagues without direct reporting lines
- Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
- Fluent English language skills
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
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. Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, click here.