The Regulatory Affairs Specialist will create and review regulatory documentation for drug, device, and combination product renewals. This role involves interacting with non-regulatory support groups to request necessary documentation, tracking the status and progress of regulatory documents, and coordinating responses to regulatory authority renewal questions under supervision.
Responsibilities
- Create and review regulatory documentation for drug, device, and combination product renewals.
- Interact with non-regulatory support groups (e.g., manufacturing, product stability, quality, clinical) to request documentation necessary to support product renewals.
- Track the status and progress of regulatory documentation used for renewals.
- Coordinate and compile responses to regulatory authority renewal questions under supervision.
- Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities.
- Answer internal queries for assigned products.
- Maintain a database of regulatory requirements for renewals.
Qualifications
- Knowledge of regulations and scientific principles.
- Strong administrative and project management skills.
- Ability to contribute to multiple projects from a regulatory affairs perspective.
- Ability to multitask and prioritize effectively.
- Excellent interpersonal and communication skills.
- Proficient in technical systems (e.g., word processing, spreadsheets, databases, online research).
- Strong proofreading and editing skills.
- Ability to independently identify compliance risks and resolve or escalate them as necessary.
Skills
- Experience in creating and reviewing regulatory documentation.
- Ability to interact effectively with cross-functional teams.
- Proficiency in tracking and managing regulatory document status and progress.
- Competence in coordinating responses to regulatory authority questions.
- Familiarity with electronic document management systems.
- Strong organizational skills to maintain regulatory requirement databases.
- Ability to manage multiple priorities and projects simultaneously.
- Excellent written and verbal communication skills.
