Director, Regulatory Affairs job in Pennsylvania

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This vacancy has now expired. Please see similar roles below...

At Proclinical, we are seeking an experienced and intelligent individual to fill the role of Director of Regulatory Affairs, based in Pennsylvania. The successful candidate will help lead the Regulatory Strategy team and direct the company's regulatory affairs activities and initiatives.

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 interactions with regulatory agencies for your projects and products.
Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including nonclinical, and clinical activities.
Support the company's commercial products.
Interact with Regulatory Affairs personnel at partner companies.
Establish and meet timelines for regulatory submissions.
Maintain awareness and communicate with team members regarding changing regulatory requirements.

Skills And Qualifications

BA or advanced degree in a scientific discipline and 10+ years of relevant experience.
Broad knowledge of regulatory affairs strategy.
A proven track record of effective collaboration with regulatory agencies, including the FDA.
Experience of with FDA REMS systems and line extensions strategy for marketed products preferred
Demonstrated leadership success in management, including building and/or leading a regulatory affairs team
Excellent written, verbal, and interpersonal communication skills.
Some travel required

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) 6463672618 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.