What are the responsibilities and job description for the Regulatory Affairs Director position at Jobleads-US?
About the Opportunity
This is an exciting opportunity to join our team as a Regulatory Affairs Director at Jobleads-US. As a key member of our regulatory team, you will play a critical role in ensuring that our products meet all necessary regulatory requirements.
Responsibilities
- Determine requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
- Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
- Develops and implements plans for timely response to HA requests and coordinates responses.
Requirements
- 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: Innovation in regulatory strategy.
- Proven ability to analyze and interpret efficacy and safety data.
- Regulatory operational expertise.
