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Head of Regulatory Affairs

Head of Regulatory Affairs (M3M - HeadofRA) New York, New York

A Head of Regulatory Affairs is needed for a company that services global biopharma companies.  This is a fully remote position. The time commitment will vary pending ramp up of drugs towards FDA approval, or meetings throughout the year with the FDA or internal alignment with partners.  Average hours will likely be around 20 hours per week.

The Head of Regulatory will report to the Company’s Chief Medical Officer. For all company assets for which accountability and responsibility for regulatory activities belong, this person will be expected to be demonstrate a high level of professionalism and personal integrity when working with internal departments and external partners. 

  • High level of experience in biopharma. Excellent working knowledge of FDA requirements and strong experience working with senior executives.
  • Fully remote position with occasional domestic and infrequent international travel
  • Highly competitive compensation
  • You will have the opportunity to work with a team of experts in a global environment.

Head of Regulatory Affairs Responsibilities:

  • As a key member of each Asset team, be accountable for oversight of all regulatory activities for the company, working closely with our regulatory consultants as needed, our regulatory vendors, and our co-development partner to consult with or inform them of our decisions. This oversight will include but not be limited to:
    • Development of regulatory strategy for each protocol on a global and country-specific basis
    • Communication with all regulatory authorities, including FDA, EMEA, APAC and other regulatory authorities, as relevant
    • Providing sound regulatory guidance and applying strategic approaches to problem-solving on the Asset Team level
    • Development and approval of regulatory plans and documentation
    • Delivery of regulatory documents and major milestones within timelines determined in conjunction with the Asset Team to best support the program/regulatory agency requirements/reviews
    • Review protocols and amendments, Statistical Analysis Plans, Clinical Study Report, and all regulatory submissions for appropriateness and correctness from a regulatory perspective
    • Ensure on time delivery of any regulatory requirements needed for communication to the FDA or global regulatory agencies
    • Oversight of all aspects of the regulatory pre-submission meetings and the submissions themselves
    • Ensuring internal audit readiness of regulatory documents
    • Supporting external regulatory audits of sites, vendors, partners
    • Ensuring the company regulatory strategy, plans, and execution including submissions remain consistent with emerging trends into regulatory science and will meet all expectations and quality standards of regulatory authorities
    • Proactively identify and resolve regulatory compliance issues
    • Ensuring all promises made to regulatory agencies are tracked and met
    • Establishing and maintaining productive professional relationships with officials in regulatory agencies
    • Management of all regulatory discussions with our co-development partners, working as a member of the Asset Team
    • Management of on-time regulatory deliverables and costs from regulatory vendors, working as a member of the Asset Team.
    • Management of all consultations and costs with our external regulatory consultants
  • Assist with corporate due diligence activities. This may include, but not be limited to, review of and comment on all correspondence with regulatory authorities and regulatory strategy of completed and planned studies.  The Head of Regulatory will also provide input on protocol design in conjunction with clinical, statistical, and compliance departments
  • Participate in overall strategic decisions, process improvement, quality assurance, and mentoring activities, as they relate to clinical development, as a member of the Senior Clinical Leadership Team
  • Communicate effectively to Executive Leadership team, other Senior Clinical Leadership Team Members, and Asset Team members.

Head of Regulatory Affairs Education and Requirements:

  • Minimum BS/BA degree, but preferably MS/PhD advanced degree in relevant field
  • 20+ years of Experience in Regulatory Affairs in the Biotech and/or pharmaceutical industries, including
    • Previous senior leadership roles in Regulatory Affairs
    • Broad scientific, technical, and regulatory understanding of large and small molecule pharmaceutical clinical product development
    • Extensive knowledgeable of regulatory processes for clinical development, from pre-clinical through approval, especially late-stage clinical development. Working knowledge of CMC and post approval regulations
    • Extensive interactions and direct communications with the FDA and EMA on late-stage clinical development programs, including end-of-Phase 2 meetings, pre-NDA and pre-BLA meetings, question and briefing book development, and NDA and BLA submissions. Similar knowledge with MHRA, PMDA, and NMPA a strong plus.
    • Knowledgeable about ongoing changes in regulatory guidance and requirements
    • Successful experience selecting and managing regulatory vendors and consultants and their costs
  • Positive, motivated, flexible team player who enjoys working a fast-paced, dynamic environment, with effective interpersonal, communication, and negotiation skills. Demonstrated behaviors/skills as a team member include Self-starter capable of strategic thinking; good listening skills; negotiating skills that maintain team unity; ability to identify multiple solutions to a problem; willingness to go the extra step to deliver quality results on time; ability to work effectively remotely; comfortable with identifying, stating, and helping to solving problems; comfortable with ambiguity
  • Computer skills include experience with PowerPoint, Excel, Microsoft Word
  • Prior small company experience is a strong plus

For additional information on this opportunity, contact Miki Miller directly at 605.215.5248. 
You can email me directly at: