Regulatory Affairs Associate
Regulatory Affairs Associate
Intellectt Inc
Boston, MA
See who Intellectt Inc has hired for this role
Location: Remote
Duration: 7 Months
Main Responsibilities
- Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to
- Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
- Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to authorities.
- Maintain annual licenses, registrations, listings and patent information.
- Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional
- Assess external communications relative to regulations. Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and
- Provide regulatory input for product recalls and recall communications.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work
assignments. May lead a departmental project team.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Participates in determining goals and objectives for projects.
- Influences middle management on technical or business solutions.
- May interact with vendors.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Regulatory Affairs Associate jobs in Boston, MA.
Sign in to create job alertSimilar jobs
People also viewed
-
Corporate Paralegal or Legal Assistant
Corporate Paralegal or Legal Assistant
-
Law Clerk
Law Clerk
-
Paralegal, (723134)
Paralegal, (723134)
MashPoint - Technology & Staffing- merged with HuMetis group Inc
-
Legal Assistant
Legal Assistant
-
Legal Researcher
Legal Researcher
-
Paralegal Specialist
Paralegal Specialist
-
Legal Secretary
Legal Secretary
-
Bankruptcy & Commercial Litigation Paralegal
Bankruptcy & Commercial Litigation Paralegal
-
Intellectual Property Paralegal
Intellectual Property Paralegal
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More