Director, Global Regulatory Affairs, Development Strategy - Permanent - MA or MD
Proclinical is seeking a Director, Global Regulatory Affairs, Development Strategy for a global biotechnology company with locations in Massachusetts and Maryland.
Primary Responsibilities:
In this role, you will develop and implement US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
The position can be based at either of their US sites (Massachusetts or Maryland).
Skills & Requirements:
Bachelor's Degree in a related discipline
Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment.
Experience providing US strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
Experience with leading major submissions and FDA meetings
The Director, Global Regulatory Affairs, Development Strategy will:
Develop and direct innovative and effective regulatory strategies in support of specific projects, and across projects in the company portfolio.
Serve as US Strategy lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Regulatory Subteam (RST) for assigned programs.
Provide advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within the company (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
Represent the company as point contact FDA and leading company delegation for regulatory authority meetings.
Lead US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorization applications, etc.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@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.