Senior RA Director
Proclinical is currently recruiting for a Director/Senior Director of Regulatory Affairs for a clinical-stage biotechnology company located in Morristown, NJ. Successful candidate will work with global regulatory team members to agree contents for timely submissions to Health Authorities.
- Define appropriate regulatory strategies to support successful global clinical development plans with focus in the US
- Provide regulatory support to inter-departmental project teams.
- Work with global regulatory team members to agree contents for timely submissions to Health Authorities.
- Coordinate the preparation and regulatory review of documents for regulatory submissions from all areas of the company.
- Ensure that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
- Direct the activities of and interacts with other departments in the preparation of initial INDs, CTAs, and regulatory dossiers for marketing applications.
- Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format for submission to obtain regulatory approvals.
- Liaise with FDA and other health authorities as needed (e.g. submissions, telephone contacts, teleconferences, meetings).
- Coordinate the preparation of responses to questions and inquiries from Health Authorities. Prepare and submit IND amendments, safety reports and DSUR in accordance with regulatory submission schedules and regulations.
- Keep employees informed of relevant regulatory guidance documents, regulations and information.
- Other responsibilities, as required.
Skills and Requirements:
- Bachelors or advanced degree (Ph.D. or Pharm.D.) in scientific/life-sciences or related field.
- Director requires a minimum of 8 years' experience in regulatory affairs. Senior Director requires a minimum of 10 years' experience in regulatory affairs.
- Oncology and biologic/cell therapy experience is highly preferred.
- Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with FDA.
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.
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