Manager, Regulatory Affairs

  • Salary: Competitive
  • REF Number: 00054757
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 18.11.2022
  • Sector: Pharmaceutical
  • Location: Zurich, Zurich/Zug Region
  • Discipline: Clinical - 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.

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.