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Regulatory Strategy Associate Director

Semma Therapeutics

Semma Therapeutics

Legal
Zug, Switzerland
Posted on Friday, February 2, 2024

Job Description

Associate Director Regulatory Strategy, Switzerland

OVERVIEW:

  • We are looking for a Swiss regulatory expert for our Swiss affiliate in Zug to grow our regulatory team and to ensure Vertex establishes and implements best practices in accordance with national requirements in Switzerland
  • Support and contribute to local Swiss cross-functional teams to achieve corporate and departmental goals and objectives
  • Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction

Native German speaker and fluent written and spoken English is essential.

KEY RESPONSIBILITIES:

Regulatory

  • Act as contact with local National Health Authority (HA) Swissmedic for regulatory activities. Submission and follow-up of local MAAs and subsequent variations for nationally approved products in Switzerland
  • Act as local contact for CTA applications and amendments
  • Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner
  • Act as local Swiss expert for regulatory queries coming from other functions, e.g. medical, commercial, market access, quality and supply chain
  • Track all Swiss HA requests and relevant new local legislation and diligently forward to relevant GRA (Global Regulatory Affairs) contact
  • Responsible for the Swissmedic submission of Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Risk Management Plan (RMP) summaries and safety signal notifications in collaboration with GPS (Global Patient Safety) and the Director Regulatory Strategy, Switzerland Lead
  • Review and approval for mock-ups, commercial artwork and product information
  • Review of promotional material according to the local Swiss requirements (AWV, Pharma Code)
  • Participate in local cross-functional launch activities
  • Local inspection and audit support
  • Ensure all work is compliant with regulatory requirements and company policies and procedures

General

  • Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.
  • Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others.
  • Ability to navigate and be successful in a fast-paced environment while delivering high quality results.
  • Excellent communication skills, strong oral/written presentation skills.
  • Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements
  • Strong analytical ability and an ability to deal with ambiguity, uncertainty and complexity
  • Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.
  • Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
  • Good interpersonal skills and ability to deal effectively with a variety of personalities

EDUCATION/EXPERIENCE:

  • Bachelor’s degree in life sciences required
  • M.Sc. or Ph.D. degree is preferred
  • Extensive relevant industry experience in Swiss regulatory affairs and understanding of current trends in local requirements
  • Experience of managing complex negotiations with Regulatory Authorities

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.