At ProClinical, we are seeking to hire a highly motivated and enthusiastic individual to take the newly-opened position of Senior Director of Regulatory Affairs, based in the United States. Reporting to the Chief Operating Officer, the remit of this role will include assuming responsibility for directing all regulatory activities from preclinical development through filing of marketing applications and post-approval activities in the United States. The ideal individual will lead an effort to obtain relevant approval for marketing products, and will provide ongoing regulatory support for products that are yet to be commercialized. This role will also comprise interactions with federal regulatory bodies (such as the US FDA), and will seek to ensure that regulatory documents are in compliance with all relevant regulations. This position is perfect for a strong leader, problem solver and negotiator, who will work dedicatedly to ensure that all aspects of production will adhere to all regulatory instructions.
- Develop and implement regulatory strategies aimed at achieving marketing approvals and appropriate product labelling in the US.
- Ensure cross-functional alignment on regulatory plans and strategies.
- Responsible for the timely production and submission of regulatory documentation.
- Ensure compliance with US FDA/ICH regulations and guidelines related to pre-clinical and clinical, regulatory submissions, product launch, labelling and promotional activities
- Serve as primary liaison with US FDA.
- Oversee the writing of pre-meeting briefing materials, lead the preparation for meetings with regulatory agencies, and ensure appropriate follow-up.
- Work closely with development teams.
- Provide guidance and technical input.
- Provide regulatory support to the business development activities.
Skills And Requirements
- BA in scientific or life sciences discipline or related, advanced degree in same strongly preferred.
- Minimum of 15 years of progressive leadership in regulatory affairs in the biotech/pharmaceutical industry.
- Clinical trial applications (CTA) to clearance.
- Experience working with the US FDA preferred.
- Experience in successfully leading submission teams for US FDA Biologics License Application (BLA).
- Expert knowledge of US FDA and EMEA and other regulatory guidelines.
- Expertise in US FDA, EMEA and other regulatory guidelines.
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 Mike Froggatt at (+1) 6467689727 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.