Posted 4 days ago

Director Regulatory Affairs


  • $165000 - $200000 per annum
  • 70748
  • Massachusetts
  • Sharon Cox
  • Permanent
  • Regulatory

Job Details


Our client is a clinical stage biotech company in the field of autoimmune disease.  This is a remote role with travel to the MA site as needed.  
DUTIES INCLUDE
• Hands on management and leadership of submissions globally, including authoring of relevant sections with SMEs, submission readiness and working with external vendors to manage timely submissions and responses
• Communicate with and present to the U.S. (FDA) and European Regulatory Authorities, and other ex US Authorities
• Oversee team preparation for, and conduct of, health authority meetings
• Provide expert advice to Product Development Teams and all internal stakeholders on regulatory matters as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Lead the development of competitive and creative regulatory plans that expedite development, maximize the probability of success, and mitigate risks
• Act as liaison with external consultants providing regulatory strategy support
• Interpret guidelines and anticipate impact of new guidelines: initiate change in response to changing environment
• Author and review relevant standard operating procedures (SOPs); ensure SOPs comply with current regulatory requirements and provide regulatory support for corporate QA efforts
• Provide guidance in the requirements and execution of documentation required for compliance
• Maintain up-to-date knowledge and understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval
Qualifications
• A self-motivated individual who maintains a sense of urgency and is comfortable with a “roll-up-the-sleeves” attitude
• BA/BS degree in life/health/technical sciences; advanced degree is a plus
• Minimum of 6-8 years of regulatory experience in the biopharmaceutical industry
• A proven track record of successful drug development resulting in global regulatory approvals
• Experience 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
• Expert knowledge of relevant FDA, EMA, ICH guidelines and regulations
• Able to guide teams through multiple stages of development with a proactive and analytical approach
• Experience with developing and implementing competitive regulatory strategies in conjunction with external consultants, and with broad regulatory knowledge across therapeutic areas; experience in immunology is 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
• Makes complex technical decisions within general functional, company and industry guidelines