Sr. Director, Regulatory Affairs

Our clinical-stage biotechnology company in Cambridge, MA is growing and looking to add a Sr. Director, Regulatory Affairs leader to their team (REMOTE or Cambridge location)!  Company is focused on rare autoimmune and diabetes diseases.  Role will provide strategic and operational regulatory oversight across the portfolio and be responsible for the development, coordination, and implementation of regulatory strategies. As the leader of this function, this role will also plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues and serve as the regulatory leader on our product development teams. 

• Maintain up-to-date knowledge and understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval
• Oversee team preparation for, and conduct of, health authority meetings
• Lead and manage regulatory submissions globally
• Communicate with and present to the U.S. (FDA) and European Regulatory Authorities, and other ex US Authorities
• Provide expert advice to Product Development Teams on all regulatory matters as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Interpret guidelines and anticipate impact of new guidelines: initiate change in response to changing environment
• Lead the development of competitive and creative regulatory plans that expedite development, maximize the probability of success, and mitigate risks
• Oversee the regulatory requirements in the design, implementation and execution of all relevant clinical trials and required registration enabling trials; integrate global regulatory understanding in developing strategy
• Provide regulatory expertise and support nonclinical and clinical areas for investigational products
• Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate QA efforts
• Provide guidance in the requirements and execution of documentation required for compliance

• BA/BS degree in life/health/technical sciences; advanced degree is a plus
• Minimum of 10 years of regulatory experience in the biopharmaceutical industry
• Expert knowledge of relevant FDA, EMA, ICH guidelines and regulations
• A proven track record of successful drug development resulting in global regulatory approvals
• Experience required with preparing regulatory documents including new INDs/CTAs, Investigator Brochures, briefing packages, PIPs and other documents for regulatory submissions worldwide
• Direct experience in leading regulatory authority meetings within different phases of drug development
• Able to guide teams through multiple stages of development with a proactive and analytical approach
• Experience with developing and implementing competitive regulatory strategies with broad regulatory knowledge across therapeutic areas preferable with experience in immunology a plus
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
• A demonstrated ability to effectively interface with and influence the management team, regulatory agencies and external partners
• Strategic thinker who can balance near term objectives with long term goals and outcomes
• A self-motivated individual who maintains a sense of urgency and is comfortable with a “roll-up-the-sleeves” attitude

This role is remote or based in Cambridge, MA; Company operates in the US Eastern Time Zone