Senior Director, Global Regulatory Strategy, Therapeutic Area Lead
Biogen
- Cambridge, MA
- Permanent
- Full-time
- Ensure optimal regulatory leadership and serve as a strategic advisory partner for assigned programs, US business, Above-Country Europe regional businesses and FDA/EMA Regulatory Agencies.
- Accountable for a seamless Global Regulatory strategy for assigned programs by collaborating closely with Global and Regional (including Japan and China) Regulatory & Business leaders
- Promote aligned, innovative Global Regulatory solutions drawing upon Global and regional regulatory expertise and strategies
- Identify the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
- Communicates global (inclusive of US and EU) regulatory strategy to senior R&D, Commercial and Business leaders
- Demonstrate knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA)/centralized Marketing Authorization Applications (MAA), and prosecution of NDA/MAAs through review to a final decision by health care regulatory authorities, specifically FDA and EMA.
- 15+ years of experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry.
- 5 years of leadership experience in a regulatory affairs management role.
- In depth and relevant Global regulatory experience (in more than one region)
- Demonstrable experience managing others and leadership
- Proven ability in developing practice rules and guidelines; Experience in interpretation of regulations (FDA, EMA, and other major health care regulatory authorities) guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Direct experience in interfacing with relevant regulatory authorities. Must foster effective, positive interactions with regulatory agencies, and corporate partners.
- Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP and GMP compliance is required
- Demonstrated experience in negotiating with and presenting to regulatory agencies (FDA/EMA).
- Prior experience of NDAs and MAAs and gaining global regulatory approvals is desirable.
- Advanced degree (Masters, PharmD, PhD) in a scientific discipline