Job Description
MAIN ACCOUNTABILITIES:
1. Responsible for the coordination of regional regulatory affairs activities for biosimilars, over and above a centralized authorization.
2. Coordination with affiliate RA to identify and complete national regulatory requirements to enable product launches.
3. Management of product updates across Countries.
The focus of this multifaceted role is on building and maintaining multiple interfaces with internal stakeholders, vendors and the affiliate RA responsible person and medical team, facilitating and overseeing national regulatory process steps, such as risk minimization measures.
Qualifications
3-4 years experience in Regulatory Affairs
Experience within Pharma or Biotech
Experience at Regional level preferred
Strong communication skills
Fluent in English
Education
Bachelor degree