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.

Job Responsibilities:

• 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 e.vagades@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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