Position Summary:
An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through global regulatory approval processes.
Key responsibilities include capturing and communicating worldwide regulatory requirements for product modifications and preparing and submitting change notifications and technical documentation to local RA contacts. The position involves coordination with internal stakeholders, and direct communication with local regulatory contacts worldwide as needed.
Primary Duties
1. Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
2. Perform assessment of change requests with minimal oversight.
3. Participate in the preparation of regulatory submissions (US, EU, Global) and additional information or responses as requested by regulatory agencies.
4. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
5. Perform interpretation of regulatory rules or rule changes and ensure their proper communication through corporate policies and procedures.
6. Write or update standard operating procedures and work instructions.
7. Begin to advise project teams on subjects such as registration requirements, compliance issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager.
8. Participate in the training of more junior regulatory personnel, as applicable.
9. Complete tasks with relatively little oversight.
10. Lead meetings and guide discussions regarding regulatory topics.
11. Lead projects with some guidance from senior regulatory employees/managers
12. Ensures accurate population of databases for tracking global product registrations.
13. Perform all work in compliance with company quality procedures and standards
14. Performs all other duties as assigned
Qualifications
Education:
Bachelor degree required
Experience:
1. 2+ years of experience in regulatory affairs
Knowledge, Skills, and Abilities
Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.
Planning objectives and strategies to achieve them within a set timeline
Informing others by sharing clear, timely information to ensure alignment
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
