Manager, Regulatory Affairs
CK QLS are recruiting for a Manager, Regulatory Affairs to join a project with a Global Pharmaceutical Company based in Zurich on a contract basis for 12 months.
Remote working: Hybrid.
Manager, Regulatory Affairs Role Objectives:
- Under supervision defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives.
- Provide regional strategic and tactical advice and guidance to teams.
- Leads the Regional Working Team and represents the region as needed on global and project teams.
- Provide 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 in the European Region for product(s).
Key Responsibilities:
- Ensure regional regulatory strategiesare 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.
- Manage, plan, and execute regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle.
- Partner with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies.
- Collaborate with Company Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed.
- Develop and maintain effective working relationships with EUCAN RA and Marketed Product Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams.
- Oversee and be accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility.
- In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
- Author and oversee execution for more complex regional regulatory strategies as needed.
- Identify regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
Qualifications:
- BSc. Advanced Scientific related degree preferred; BA accepted based on experience. Advanced degree preferred.
- A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 6 years regulatory and/or related experience.
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU.
- Understand and interpret complex scientific issues across projects and therapeutic area(s).
- Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region with global involvement also preferred.
- Proactively identifies regulatory issues; offers creative solutions and strategies.
- Experience managing relationships with CROs and/or contractors also preferred.
Apply: For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondencein English. Please quote reference 54757 in all correspondence.
