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Regulatory Affairs Manager - Pharma
This vacancy has now expired. Please see similar roles below...
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Affairs Manager to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success.
Responsibilities
- Track, compile and maintain full regulatory applications including initial INDs and NDAs.
- Maintain timelines for full regulatory submissions.
- Provide regulatory advice and guidance to other departments, ensuring compliance with FDA regulations and requirements.
- Interact with FDA and other regulatory agencies.
- Develop scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the FDA.
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
Skills And Qualifications
- BA and 7 years regulatory affairs experience, OR Master's degree and 5 years regulatory affairs experience.
- Experience with FDA and other regulatory agencies is preferred.
- Strong written, verbal, and interpersonal communication skills.
- This position may require supervision of junior level staff.
- Less than 10% travel required.
To Apply:
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 call Reid Schalet at (+1) 6463672908 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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