Associate Director Regulatory Affairs
vor 2 Wochen
Location: Baar, Switzerland
Job reference: R-192738
Date posted: 02/21/2024
**This is what you will do**:
Reporting to the Head of CENE Regulatory and Quality Affairs (RQA), this position is responsible for providing proactive strategic regulatory support and advice to the VP CENE Area Head, Head of CENE RQA and the Country Directors of the CENE region. The position will support and advise the Head of CENE RQA to develop and drive a regulatory vision and direction for the CENE Regional Business. The CENE Region consists of:
- The Alpine Region (Switzerland and Austria),
- The Nordics Region (Norway, Sweden, Finland, Denmark and Iceland), and
- The Netherlands.
The Associate Director, CENE Regulatory Affairs will ensure countries in the CENE region remain fully compliant with all local regulations and corporate policies and act as the main contact person accountable for regulatory activities in the CENE region.
**You will be responsible for**:
- Providing proactive strategic regulatory support and advice to the VP CENE Area Head, Head of CENE RQA and the Country Directors / General Managers of the CENE region.
- Providing proactive support in aligning with global RA functions and supporting early RA submissions in CENE markets
- Planning and driving regulatory direction for the CENE regional business.
- Monitoring the development of local CENE regulatory requirements / guidance documents / intelligence and advise partners on the impact on the business, Alexion portfolio and pipeline, while actively shaping the CENE regulatory environment for optimal outcomes through active participation on new regulation discussions, commenting on draft guidelines etc.
- Influencing local regulatory teams to deliver on local responsibilities outlined in regulations, policies, and internal standards, aligned with business priorities in addition to leading innovative sustainable solutions implementation in the region, for example, electronic product information.
- Oversee CENE country affiliates input to regulatory strategies for portfolio products in development, as well as for the approved products in terms of life cycle management. Ensure relevant regulatory information is available for timely forecasting and supply processes.
- Partner and coordinate with Commercial, Medical Affairs, Business Operations and Management (Medical Directors, GMs etc.) to define regulatory priorities based on business opportunities and the affiliate’s business objectives.
- Accountable for overseeing/monitoring local regulatory submissions in coordination with Local CENE Regulatory personnel and other Global Regulatory and Quality functions.
- Assure appropriate escalations and notification to line management.
- Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GxP requirements.
- Drive digitalisation and simplification of regulatory Alexion processes to support the CENE LT and local teams.
**You will need to have**:
- Bachelor’s degree, preferably in life sciences. Advanced degree (PharmD or PhD) preferred.
- 8 years of hands-on Regulatory 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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