Senior Regulatory Affairs Specialist
Location: Bedford, MA
The role of the Senior Regulatory Affairs Specialist is to execute on the global regulatory programs in accordance with current global regulations. The individual will coordinate the collection of information and documentation and compile into submissions, license renewals, periodic updates and registrations to regulatory agencies and partners worldwide. The individual will be responsible for the review of labeling, protocols, product development and manufacturing documents for compliance with regulatory requirements.
Strategic Focus Areas:
The Senior Regulatory Affairs Associate will plan a key role as the executor of the corporate regulatory strategy. This individual will provide input into regulatory programs and ensure that the organization stays compliant to worldwide regulatory requirements.
- Collect and coordinate documentation to prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners
- Compile materials for license renewals, updates and registrations
- Review labeling and labels for compliance with regulatory filings
- Review preclinical and clinical protocols and reports for compliance with GLP and GCP requirements, respectively
- Maintain regulatory files/database and chronologies in good order
- Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Maintain current knowledge of international regulation, guidance and standards applicable to Anika products
- Research regulatory issues and disseminate regulatory information to Production, QA/QC, and R&D departments and senior management
- Stay current on changes in regulations and agency guidance
- Responsible for other duties and projects as assigned
Exercises judgment within defined procedures. Works on problems of moderate to diverse scope. Normally receives general instructions on routine work, detailed instruction on new assignments.
Bachelor’s degree, preferably in life sciences or related field
Desired Experience, Knowledge, and Skills:
- 5+ years of regulatory affairs experience
- International experience is a plus
- Strong understanding of global regulatory processes
- Excellent project management skills with the ability to multi-task
- Ability to work autonomously, effectively manage time and deliver results on time
- Excellent presentation skills, both written and in platform presentation format
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.