What are the responsibilities and job description for the Associate Director Regulatory Affairs position at EPM Scientific - Phaidon International?
Title : Associate Director Regulatory Affairs
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.
A small but growing clinical stage company is seeking an Associate Director Regulatory Affairs to join the team in a remote capacity. They are seeking a well-rounded RA professional to lead the Regulatory Strategy for their pipeline of phase III products in the rare disease space.
Responsibilites :
- Serves as regulatory affairs representative to provide input on global clinical trials, including coordination of health authority requests, filing activities, and ensuring that documentation and reporting systems are maintained and compliant.
- Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions.
- Contributes to the strategy for US FDA interactions with the cross-functional team, including development of content, format, and accountability for regulatory submissions and related supplements and amendments, such as FDA meeting requests, briefing books, meeting minutes, orphan drug annual reports, and DSURs.
- Supports maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams.
- Supports US labeling development for NDA.
- Delivers regulatory achievements for assigned project(s), including the assessment of risks with mitigation strategies, emerging data, and the probability of regulatory success.
- Develops collaborative and effective relationships across key internal and external partners (e.g., regulatory CMC, regulatory operations, CROs / vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals.
- Leads cross-functional teams, in partnership with global regulatory lead, to develop and execute regulatory strategies for assigned projects and programs.
Requirements / Key Attributes :
J-18808-Ljbffr
