Contractor Regulatory Affairs Associate, with a focus on clinical and nonclinical aspects, will participate as a member of the regulatory team in the development and implementation of global regulatory strategy worldwide for products serving patients with rare diseases and unmet medical needs. This individual will be responsible for assisting with the development and coordination of regulatory submissions, with input from cross-functional team members, to support regulatory filings, agency meetings, and overall program priorities.
Responsible for organization of cross-functional activities pertaining to regulatory function, including the development of meeting requests, timelines, and compilation of briefing documents intended for submission to regulatory authorities.
- Actively participate in regulatory meetings on defined topics with a clear objective. Author and archive meeting minutes.
- Maintain regulatory dossiers in compliance with global health authority requirements.
- Participate in the development of regulatory submissions for assigned products and regions.
- Interact with other global project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
- Interact with internal and external partners as necessary to support product development.
- Conduct and analyze regulatory research to understand past precedence and the current competitive landscape.
- Educate internal stakeholders on implications of regulations.
- Provide logistical support for meetings with US and ex-US regulatory agencies.
- Support the preparation of responses to questions and comments from regulatory agencies.
- Support the filing and archival of regulatory documents, study reports, etc.
- Minimum 4 years of regulatory affairs experience or equivalent combination with advanced degree.
- Understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Experience with global regulatory dossiers desirable.
- Excellent written, verbal, and organization skills, with strong attention to detail.
- Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner.
- Preferred experience with eCTD document formatting and publishing, and the use of regulatory authoring templates.
Bachelor’s degree required. Prefer life sciences or related major.
Contract for 1-6 months.