We're looking for a Regulatory Affairs Director, working in the Pharmaceuticals & Medical Products industry in Cambridge, Massachusetts, United States.
Leads the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.
Provides strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support company’s R&D objectives.
Develops and creates regulatory strategies for multiple clinical development projects from early to late-stage clinical development.
Coordinates all aspects of the preparation, review and submission of regulatory documents.
We are offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelor degree in a relevant scientific discipline. Masteral or an advanced degree (PhD, PharmD) is preferred.
8-10 years of regulatory affairs experience in the pharmaceutical industry.
Experience with development of regulatory strategies in oncology is preferred.
Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements.
Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC).
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.