Regulatory Contractor

12-03-2024
Job Type
Contract
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Hourly

Job Description

Regulatory Contractor - full-time, 12 months, ASAP start date

One of our key clients, a Rare Disease Swiss Biotech, is recruiting a contractor to support their commercial portfolio, and development pipeline if needed. They are an extremely close knit team, and therefore this is a hybrid position. 

  • Supports EU regulatory activities for assigned activities and programs, in conjunction with the Regulatory Affairs International and under the leadership of the Associate Director of Regulatory Affairs.
  • Performs critical review of submission documents to ensure compliance with regulatory requirements.
  • Contributes to and reviews responses to international health authority questions to ensure appropriate, consistent, and complete answers to health authority questions; ensures responses are aligned with global development strategy.
  • For commercial products, leads lifecycle management activities (i.e. variations, submission management).
  • Supports orphan designation development activities and paediatric investigational plans, if required.
  • Represents the Regulatory Affairs function at cross functional submission and study management team meetings.
  • Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to product teams.
  • Organizes and maintains hard copy and electronic department files including approvals/licenses/authorizations for international marketing authorizations and activities.

Consultant