Director/Sr. Director, Global Reg Affairs

Proclinical, in support of our client, are seeking an individual to fill the role of Director/Senior Director of Global Regulatory Affairs, based in Wilmington, DE. The successful candidate will work with multi-functional teams to develop the regulatory strategy and ensure that regulatory requirements for assigned products are complete. The position will liaise and lead team meetings with FDA and other Health Authorities.

Responsibilities

• Define appropriate regulatory strategies to support successful global clinical development plans with focus in the US, EU, and Japan.
• Provide regulatory support to inter-departmental project teams.
• Evaluate and define regulatory requirements needed for clinical trial applications and marketing approval applications in targeted regions.
• Advise scientists of any scientific/regulatory issues that will have an impact on drug development.
• Work with global regulatory team member to agree contents for submissions to health authorities.
• Coordinate the preparation and review of documents for regulatory submissions.
• Ensure that data provided is presented clearly and succinctly to optimize the regulatory review and approval process.
• Direct the activities of and interact with other departments in the preparation of initial INDs, CTAs, VHPs and regulatory dossiers for marketing applications.
• Work with Regulatory Operations group to ensure preparation of relevant documents in the required format for submission to obtain regulatory approvals.
• Liaise with FDA and other health authorities as needed.
• Coordinate the preparation of responses to questions and inquiries from Health Authorities. Prepare and submit IND amendments, safety reports, DSUR and NDA annual reports in accordance with regulatory submission schedules and regulations.
• Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
• Keep employees informed of relevant regulatory guidance documents, regulations and information.

Skills And Qualifications

• BA or higher in related scientific field and 5+ years of direct responsibility for regulatory affairs and 8+ years of drug development experience. Senior Director requires 10+ years of experience in regulatory affairs with 7+ years of drug development experience.
• Oncology experience is highly preferred.
• Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with international regulatory agencies.

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 Kyle Weber at (+1) 646-367-2618 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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