Clinical RA Manager
Proclinical is currently recruiting for a Clinical Regulatory Affairs Manager for a pharmaceutical company located in Princeton, NJ. Successful candidate will interface with functional areas to identify and obtain information required for regulatory submissions.
- Regulatory project management.
- Create and maintain regulatory timelines and track deliverables.
- Prepare and submit regulatory documentation.
- Develop and/or review regulatory documents to ensure that all submissions are of high quality.
- Prepare/coordinate/file/manage the nonclinical, clinical and CMC content of IND/CTAs, annual reports, and information amendments in multiple countries.
- Support the preparation and filing of the regulatory applications (IND/CTA, NDA/BLA/MAA).
- Provide strategic input and regulatory advice to the project teams on development programs.
- Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.
- Interact with Health Authorities.
- Interface with global regulatory authorities and consultants as needed.
- Lead/coordinate the preparation of responses to questions from Regulatory Authorities.
- Support the preparation and conduct of Agency meetings as necessary.
Skills and Requirements:
- Minimum Bachelor's degree in Pharmacy, Biology, Chemistry or related healthcare functional area; advanced degree preferred.
- Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
- Extensive experience in preparation, submission and approval of INDs/CTAs and marketing applications (NDA/BLA/MAA).
- Proven ability to successfully manage major submissions and critical projects timelines.
- Experience in addressing clinical-related regulatory queries from global health authorities.
- Experience with leadership role in HA negotiations.
- Excellent medical writing, communication and management skills.
- Professional Training.
- Regulatory Affairs Certification (RAC) preferred.
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 Nicholas Walker at (+1) 646-367-2908 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.
Proclinical Staffing is an equal opportunity employer.