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Director, Regulatory Affairs

Company: Anokion
Location: Cambridge
Posted on: November 25, 2022

Job Description:

Director, Regulatory AffairsAbout UsAnokion SA is a clinical-stage biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion's distinct approach leverages the company's immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease. For more information, visit Job SummaryAnokion is seeking a Director, Regulatory Affairs, a critical role which will provide strategic and operational regulatory oversight across the portfolio of Anokion SA and its fully owned subsidiary Kanyos Bio. The Director, Regulatory Affairs will be responsible for the development, coordination, and implementation of regulatory strategy, documentation, submission files and communication with regulatory agencies. As the leader of this function, this candidate will also plan and direct projects and provide technical background, leadership, hands on operational oversight and consultation to cross-functional colleagues and serve as the regulatory leader on our product development teams.In addition to managing the regulatory organization, the Director, Regulatory Affairs will build strong relationships with regulators and external regulatory experts to ensure best practices in regulatory filings and handling of any regulatory requests.This position will report to the Chief Medical Officer and the company is based in Cambridge MA. This role can be remote with travel to Cambridge, MA as needed/dictated by business necessity. Anokion operates in the EST time zone.Responsibilities and Duties

  • 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 approvalQualifications
    • 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

Keywords: Anokion, Cambridge , Director, Regulatory Affairs, Executive , Cambridge, Massachusetts

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