Regulatory Affairs Lead

Vor 4 Tagen

Basel, Schweiz Hays Vollzeit

**My duties**
- Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
- Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Leads the Regional Working Team and represents the region as needed on global and project teams
- Provides regional regulatory expertise for assigned development and /or life cycle management projects within the therapeutic area of responsibility
- Under supervision from a senior team member and/or Line Manager sometimes manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s) within their responsibility.
- Ensures regional regulatory strategies are written, reviewed and executed according to plan
- In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
- Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle

**My qualifications**
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- Experience within the pharmaceutical industry and experience in regulatory affairs in development and /or post-marketing phases in the EU
- Experience managing relationships with CROs and/or contractors
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy
- Able to understand broad concepts within regulatory affairs and implications across the organization and globally
- Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
- Generally strong in working well with others, within global teams and communicating with senior leadership

**My benefits**
- Global pharma company
- HO possible

**About Hays**
- With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.**My contact at Hays**

**Reference number**
659137/1

**Contact**
Phone: +41 44 225 50 00

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