Regulatory AD/Director

At Proclinical, we are seeking an individual to fill the role of Associate Director/Director of Regulatory Affairs, based in New Jersey. The successful candidate will be responsible for developing, coordinating and executing regulatory strategies, and will provide guidance to staff regarding appropriate regulatory strategies with respect to nonclinical and clinical aspects of the programs.

Responsibilities

• Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development.
• Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams.
• Lead regulatory interactions with health authorities, marketing partners, and vendors for their products/projects.
• Review and approve labeling for the company's products.
• Ensure the timely submission of INDs, NDAs, amendments, and supplements for their products/projects.
• Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization.
• Author and maintain IND and NDA applications, supplements and annual reports pertaining to ongoing application maintenance in accordance with established timelines and submission dates.
• Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling.

Skills And Qualifications

• BA in a related field (advanced degree preferred) and 6+ years of industry experience, with 4-6 of those in a Regulatory Affairs function/department.
• Experience in oncology/rare diseases drug development preferred.
• Experience with preparation of major regulatory submissions and supportive amendments or supplements.
• Demonstrate strong organizational skills.
• Excellent written, verbal, and interpersonal communication skills.

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 Tudor Carr at (+1) 617-545-5919 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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