Sr Director, Global Regulatory Counsel

The Global Regulatory attorney will serve as a key business partner to Biogen’s Global Safety & Regulatory Sciences team and advise on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations.

The successful candidate will have direct client responsibility in support of a broad range of regulatory activities, providing strategic and solutions-oriented legal advice in the development of innovative, breakthrough global regulatory strategies for product development and approval. This attorney will work closely with other attorneys in the legal department and senior leaders within the organization. This position reports directly to the Chief Research, Development & Operations Counsel.

Specific responsibilities may include:
• Review and advise on key global regulatory filings and briefing documents
• Work with cross functional team to develop product target profile and target labeling; anticipate and advise on label and approval challenges; and advise on regulatory exclusivities and life cycle management of products.
• Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products.
• Advise Drug Safety on recent developments in risk management
• Proactively identify and manage risk profile of products in development to be best prepared to prevent and address clinical trial and post marketing products liability claims.
• Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments.

• 12+ years experience with global regulatory requirements in the bio/pharma industry required.
• Experience with regulatory submissions, requirements and drug safety management is required.
• Experience with government affairs, FDA and EMA regulations

Biogen is seeking an experienced healthcare attorney with significant, specialized experience with global regulatory requirements in the bio/pharma industry.