Regulatory Affairs Specialist
About The Position
We're looking for a meticulous and analytical Regulatory Affairs Specialist to join our team in Milford, United States. This outstanding opportunity at LGC will allow you to be at the forefront of regulatory excellence and conformity, ensuring our organization competes successfully in the global marketplace. In this role, you will be responsible for ensuring our organization maintains full compliance with all applicable federal, state, and international regulatory requirements. The ideal candidate will demonstrate careful organizational skills, strong communication abilities, and a dedication to maintaining the highest standards of regulatory excellence. You will work collaboratively with cross-functional teams to navigate complex regulatory landscapes and drive timely product approvals.
Requirements
- Minimum 3-5 years of experience in regulatory affairs, compliance, or quality assurance
- Bachelor's degree in a relevant field of study
- Strong knowledge of FDA regulations, Code of Federal Regulations (CFR), and Good Manufacturing Practices (GMP)
- Proficiency in preparing and managing regulatory submissions and documentation
- Excellent written and verbal communication skills with the ability to translate complex regulatory requirements into clear mentorship
- Advanced organizational and project management skills with the ability to prioritize several tasks simultaneously
- Proficiency with regulatory databases, electronic submission systems, and standard office software
- Strong analytical skills with the ability to interpret regulatory mentorship and industry standards
- Attention to detail and dedication to accuracy in all regulatory documentation
- Experience working cooperatively with diverse groups in a fast-paced environment
- Professional demeanor and ability to interact effectively with regulatory agencies and external partners
Nice To Haves
- Experience in the pharmaceutical, medical device, or healthcare industry
- Experience with global regulatory standards (European Union/IVDR, Canada, or other regions)
- Knowledge of quality assurance processes and procedures
- Experience with electronic submissions and digital regulatory systems
- Understanding of product lifecycle management from development through commercialization
- Advanced Excel skills and/or database experience
Responsibilities
- Prepare, review, and submit regulatory documentation and applications to the FDA and other regulatory agencies
- Analyze and interpret regulatory requirements, mentorship materials, and industry standards to ensure organizational compliance
- Maintain comprehensive knowledge of current and emerging regulations affecting product development, manufacturing, and commercialization
- Develop and implement regulatory strategies for new product launches and existing product modifications
- Coordinate with quality assurance, research and development, and manufacturing teams to gather necessary information for regulatory submissions
- Monitor regulatory changes and communicate updates to relevant collaborators
- Maintain organized regulatory files and documentation systems in compliance with record-keeping requirements
- Conduct regulatory impact assessments and provide recommendations to senior management
- Support internal and external audits related to regulatory compliance
- Track regulatory timelines and ensure all submissions meet established deadlines
- Interact with regulatory agencies about submissions, inquiries, and compliance matters
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
