Job Description:
Regulatory Affairs Specialists play a pivotal role in the pharmaceutical, biotechnology, and medical device industries. Their expertise is crucial for ensuring compliance with regulatory requirements and facilitating the smooth progression of clinical trials and market authorizations.
CORE RESPONSIBILITIES:
* Submission Coordination: Oversee the planning, execution, and completion of regulatory submissions, including CTA, IND, MAA, PIP, Scientific Advice, to ensure accuracy, timeliness, and compliance.
* Dossier Management: Coordinate the submission of dossiers and follow-up responses via relevant portals (e.g., SPOR, IRAS, CTIS).
* Document Development: Act as primary liaison with clients for submission projects, maintaining proactive communication to understand objectives, oversee timelines, provide updates, and address queries.
* Expert Advisory Services: Offer expert advice on developing submission documents, strategies, and plans, ensuring alignment with client development timelines.
BENEFITS:
This role offers opportunities for strategic thinking, issue resolution, and acting as a trusted advisor to clients for routine and complex submissions. Opportunities also exist to shape internal processes, improve submission strategies, and directly influence the client experience.