Regulatory Affairs Manager
About the role
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- Effectively manage Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON.
- Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be concerned with: Agrochemicals, Cosmetics, Foods, Medical Devices and Veterinary products. Works on a range of regulatory issues in which analysis of situations or data requires an in-depth evaluation of diverse factors.
- May work either alone or as part of a regulatory or cross-functional team depending on the size and nature of increasingly complex projects.
- Act as Regulatory Project Lead but may also report to another Regulatory Project Lead as required.
- If acting as Regulatory Project Lead, responsible for managing each project and for monitoring and reporting progress and is accountable for all matters relating to that project and for communication with the client.
- Represent the Regulatory Affairs Department in business development activities.
- To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
- Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
- As a manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
- Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
- Primary point of contact between ICON and the Client
- Management of the designated project in accordance with the agreed project planning and control documentation, including initiation and maintenance of the project plan
- Management of the assigned regulatory project team
- Production of project status reports at agreed intervals
- Ensuring that checking and auditing procedures are carried out
- Control of all project related documentation either in paper or electronic form
- Monitoring and advising on compliance with agreed budget relating to the project
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Minimum five years Pharmaceutical/CRO experience including minimum 5-7 years Regulatory Affairs experience or equivalent
- EU/APAC: In depth proven experience in regulatory affairs or aligned work.
- Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction
- Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Excellent written and communication skills
- Good written and spoken English.
- Proficient in the use of Microsoft Office.
- Bachelor’s degree, or local equivalent, preferably in the sciences, or equivalent experience qualification. Masters degree or higher preferred.
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