A leading pharmaceutical company is advertising a vacancy for a Regulatory Manager, to be based in their European office. This is an exciting opportunity to bring skill and expertise to a dynamic role and bolster a career in the regulatory field.
- Support regulatory team and product development teams in all aspects of regulatory affairs.
- Ensure the preparation of high-quality regulatory documents including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions, and other regulatory filings to support regulatory compliance.
- Provide regulatory input in a timely manner.
- Act as point for internal and external clients.
- Support GxP compliance, inspections, and regulatory systems.
- Remain up to date on global regulatory requirements.
Skills and Requirements:
- Knowledge and understanding of US, EU, Canada, and ICH guidelines and experience of working to GxP.
- Understanding of in vitro device/companion diagnostic regulations is a bonus.
- Direct experience in preparation of regulatory submissions including briefing documents, and/or MAAs/NDAs and post-approval submissions.
- Experience of meeting with the EMA and European national regulatory authorities.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.