Job Description

REQUIRED SKILLS:

• 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.

EDUCATION:

• Advanced degree (Masters, PharmD, PhD) in a scientific discipline
  

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Additional Information

ABOUT THE ROLE:

The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease space.
This role will provide strategic regulatory input to regulatory product teams and cross-functional development teams responsible for global programs. Ensure effective communication and constructive working relationships within the Biogen matrix. Collaborate closely and set appropriate expectations with Biogen business partners as well as representatives of regulatory authorities / agencies and have budget/personnel resource oversight.

WHAT YOU’LL DO:

• 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.