Associate Director, Regulatory Affairs - Boston, MA - Permanent

Proclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston, MA.

Primary Responsibilities:

The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of finished products and uphold high standards of compliance for transportation, storage, and commercial distribution. The role also involves providing quality support to commercial affiliates and overseeing in-country distribution and Global Logistics providers, including Quality KPI and metrics reporting.

Skills & Requirements:

• B.S and/or M.S. degree, advanced degree or education in a scientific field is a plus.
• Comprehensive knowledge of the drug development process.
• Demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc).
• Experience in oncology or rare disease.

The Associate Director will:

• Develop and execute innovative regulatory strategies for our development programs, including the implementation of non-clinical and clinical regulatory strategy for relevant products.
• Lead the preparation and submission of high-quality domestic and global regulatory submission documents.
• Communicate with global regulatory authorities and lead the preparation and conduct of meetings with health authorities.
• Integrate knowledge of current legislation, guidelines, and other regulatory intelligence into the development strategies and ensure compliance with regulatory filing and reporting requirements.
• Proactively identify regulatory opportunities and risks and propose alternative approaches and mitigations to resolve development program challenges.
• Plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at ( 1) or .

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.