Director of Global Regulatory Strategy - Permanent - Boston, Massachusetts MA

Proclinical is seeking an individual experienced in Global Regulatory Strategy. This is a temporary contract position which holds a hybrid working module and is based in Boston, Massachusetts.

Primary Responsibilities:

This role is perfect for an individual who thrives in a fast-paced environment and is passionate about developing and implementing regulatory plans for complex products aimed at addressing rare diseases and unmet medical needs. The successful candidate will be a key player in a diverse and ambitious team, contributing to the successful registration and life-cycle management of products.

Skills & Requirements:

• Strong knowledge of US drug development and regulatory policy.
• Proven knowledge on providing US strategic regulatory advice for the global development of products.
• Experience with running submissions and FDA meetings.
• Ability to manage complex issues and coordinate multiple projects simultaneously.
• Strong interpersonal and written/verbal communication skills.
• Proven track record practicing sound judgment as it relates to risk assessment.
• Highly conversant and knowledgeable of new and emerging regulations and guidances.
• Bachelor's Degree in a related discipline.

The Director of Global Regulatory Strategy's responsibilities will be:

• Develop and direct innovative regulatory strategies for specific projects and across projects in our portfolio.
• Serve as the global or US Strategy lead on assigned programs.
• Provide advice on regulatory issues for both marketed and pipeline products.
• Represent the company as the point of contact with the FDA and lead the company delegation for regulatory authority meetings.
• Lead US submissions to regulatory authorities in support of proposed and ongoing development programs.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
• Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.

If you are having difficulty in applying or if you have any questions, please contact Kylie Williams at ( 1) 267 523 2542 or k.williams@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.