- 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.
- 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
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Stratacuity Boston, United StatesLocation: · Boston, MA(Remote) · Check out the role overview below If you are confident you have got the right skills and experience, apply today.Therapeutic Areas : NeuroJob Overview: · The Associate Director/Director will develop and implement global regulatory strategies, s ...
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Stratacuity Boston, United StatesLocation: Boston, MA(Remote) · Check out the role overview below If you are confident you have got the right skills and experience, apply today. · Therapeutic Areas: Neuro · Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, ...
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Stratacuity: Proven Scientific Placement Boston, United StatesLocation: Boston, MA (Remote) · Therapeutic Areas: Neuro · Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation, amendments, and ...
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BioSpace Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
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Takeda Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Takeda Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
Regulatory Affairs Associate - Boston, United States - INTELLECTT INC
Description
Role: Regulatory Affairs AssociateLocation: Remote
Duration: 7 Months
Main Responsibilities
Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work
assignments. May lead a departmental project team.
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