Director, Regulatory Affairs North America
Proclinical is currently partnered with a global specialty pharma focused on marketing therapeutic solutions for patients with life-threatening conditions and chronic illness.
At present, Proclinical's client is looking to onboard a Director of Regulatory Affairs to join their reputable and fast-growing organization, located in Boston, MA.
- Guarantee post-marketing regulatory compliance, contribute to the preparation of submissions and monitoring of applications submitted to FDA.
- Direct, plan, and implement regulatory operations for products, line extensions, and licensed products.
- Lead staff training and ensure regulatory compliance.
- Prepare product development strategies.
- Serve as liaison with FDA and other agencies.
Skills and Requirements:
- Minimum of MS in scientific, pharmaceutical, or related field.
- At least 10 years of experience within Regulatory Affairs within the pharmaceutical industry.
- Experience in late phase, life cycle management.
If you are having difficulty in applying or if you have any questions, please contact Emma Vagedes-Plavcan at (+1) 347-694-4446 or email@example.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.