Global Senior Regulatory Affairs Consultant

vor 5 Stunden

Bern, Schweiz Consultys Switzerland Vollzeit
Job Description

The Global Regulatory Lead (GRL) Consultant is a member of a GRA Global Product Strategy Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as:

  1. Regulatory leaders, who drive development and implementation of innovative, scientifically sound, prospective, global regulatory strategies for product/s, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome.
  2. GRA representatives on Product/Project Strategy Teams (PSTs), key Delivery Teams (e.g., Clinical Development Teams [CDTs], Safety Management Teams [SMTs], Evidence Access Strategy Team [EAST]), and internal governance meetings as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective product/s.
  3. GRAST Leaders, engage GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability and ‘team spirit’, drive alignment, act as decision maker for Team as needed, assess and communicate regulatory outcomes, encourage review/discussion, and contribute to or approve project-related deliverables (e.g. GRSO, TPP, TPC, CCDS, Protocol, CTD clinically-related sections, cross-functional education and influence Regulatory Intelligence/Policy) for the Team.
Required Profile

Requirements :

  1. Minimum 4-year university degree (or equivalent) in scientific field (e.g., biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree desired (e.g., PhD, MS, MBA).
  2. Minimum of 10 years biotech/pharmaceutical industry, with 5 years regulatory experience, including 3 years in development.
  3. Direct agency interaction experience, preferably ICH regions, as well as exposure across multiple ICH health authorities.
  4. Team leadership experience, preferably 3 years as direct or matrix manager.
  5. Clinical (or Device/Combination Product) regulatory experience desired.
  6. Exposure to market access activities is desired.
  7. Applies Servant Leadership and Team Player principles to team environment, including leading without authority.
  8. Developing strategic ability to assess product vision and apply regulatory lens to effectively articulate regulatory assumptions, opportunities, and risks.
  9. Experience working effectively across cultures, inclusive and seeks out alternative perspectives when assessing potential outcomes.
  10. Fluent in English (written & verbal).
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