Director / Senior Director Regulatory Affairs

Proclinical is currently seeking a Director/Senior Director of Regulatory Affairs for a biotech company located remotely in New Jersey. Successful candidate will be responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company.

Job Responsibilities:

• Defining appropriate regulatory strategies to support successful global clinical development plans with focus in the US
• Providing regulatory support to inter-departmental project teams.
• Working with global regulatory team members to agree contents for timely submissions to Health Authorities.
• Ensuring that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.
• Directing the activities of and interacting with other company departments in the preparation of initial INDs, CTAs, and regulatory dossiers for marketing applications.
• Working 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.
• Liaising with FDA and other health authorities as needed.
• Coordinating the preparation of responses to questions and inquiries from Health Authorities.
• Preparing and submitting IND amendments, safety reports and DSUR in accordance with regulatory submission schedules and regulations.
• Keeping employees informed of relevant regulatory guidance documents, regulations and information.

Skills and Requirements:

• BS, MS, PhD or PharmD in scientific/life-sciences or related field.
• Director requires 8+ years' experience in regulatory affairs. Senior Director requires 10+ years' experience in regulatory affairs.
• Oncology and biologic/cell therapy experience is highly preferred.
• Excellent oral and written communication skills.
• Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with FDA.

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 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.

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