Regulatory Affairs Manager

4 weeks ago

Cambridge, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs
  • This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities.
  • Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients and Performance
  • Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure dept expertise and to meet department goals.
  • Identify issues and address them in a timely manner, including preventive actions.
  • Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements.
  • Initiate regulatory submission when required and support ICON team with Regulatory Inspections
  • Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors.
  • Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
  • Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
  • To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, GXP and appropriate regulations and guidelines.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Requirements:

  • FDA 510K, FDA QSR (3+ years experience).
  • Excellent written and oral communication skills
  • Good written and spoken English.
  • Strong technical writing and editing skills.
  • Travel (approximately 10-20%) domestic and/or international.

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