Senior Regulatory Affairs Director - Permanent - Remote
Proclinical is seeking a Senior Regulatory Affairs Director - Drug/Combo Products for a global mid-sized medical diagnostics company. This is a permanent role with the opportunity to work remotely.
Primary Responsibilities
In this role, you will be responsible for Regulatory Affairs for both drug products and medical devices and must ensure that currently marketed and potential new products meet the regulatory requirements of the United States FDA and Health Canada for drug products, and worldwide for medical devices. You will be responsible for the management, direction, performance, and accountability of the local Regulatory Affairs staff based in North America.
Skills & Requirements:
- Minimum of a Bachelor's degree in a scientific or health related discipline. A higher degree is strongly preferred.
- Minimum of 10 years' regulatory experience related to drug products and/or medical devices in the USA. Demonstrated success in dealing with US FDA.
- Experience and knowledge of current FDA requirements; experience handling interactions with FDA
- Regulatory experience in Canada would be an important asset as would experience of global product development of drug products and/or medical devices.
- Experience in managing personnel required.
- Must be eligible to work in the US.
The Senior Regulatory Affairs Director will:
- Development of strategic plans for development and post-approval regulatory submissions to support business needs and to ensure alignment of regulatory strategies with overall business strategy.
- Understanding of practical regulatory requirements for submissions in the US and Canada for drug products, and in the US, Canada, EU, Australia and Japan for medical devices.
- Liaise with and successfully negotiate regulatory strategies with Health Authorities in the territory.
- Develop and/or execute regulatory plans for new products, new designs, reformulations, manufacturing and packaging changes, and other projects.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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