Regulatory Affairs Associate

4 weeks ago

Boston, United States INTELLECTT INC Full time
Role: Regulatory Affairs Associate

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

assess regulatory implications for approval.

  • 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

items.

  • 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

product associated events are reported to regulatory agencies.

  • 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.

Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

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

erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
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