Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
20-06-2025
Employer Active
1 Vacancy
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Job Description
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 ICONs values which centre 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 SOPs and internal systems 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.
- 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.
Employment Type
Full Time
Key Skills
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