• Director, Regulatory Development Strategy Global Regulatory Leader

    Job Locations US-MA-Lexington
    Job ID
  • Overview


    This is an outstanding opportunity for an experienced regulatory professional in drug development and regulatory strategy in the biotech arena to join motivated and newly formed Regulatory Science & Pharmacovigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.


    The RSP aims to maximize opportunities for product approval, its safe use and further development by:


    • Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
    • Delivering regulatory milestones and timely registration throughout the product lifecycle
    • Ensuring patient safety by early identification of safety signals, building robust PhV systems and preparing for post-marketing commitments
    • Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration


    The Company is seeking an experienced regulatory leader with over 13 years of experience in the international pharmaceutical industry or consultancy and at least 10 years in global regulatory strategy with proven track record of business impact. Management experience of cross-functional team over 5 years is a prerequisite. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and defending the regulatory position with global health authorities.


    The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.


    • Provide strategic regulatory leadership to project teams to support the planning and conduct of clinical & CMC development leading to successful and fast registration
    • Identify issues from research, early development and evolving competitive intelligence that potentially would impact regulatory approval (risk analysis)
    • Manage development projects with multiple, complex issues requiring extensive agency consultations and contingency and risk mitigation planning
    • Assesses project plans and timelines effectively to ensure projects are appropriately prioritized and key goals are met on time
    • Evaluate current regulatory processes and communication links and assess opportunities for improvement
    • Innovative thinker with agility to create regulatory pathway for accelerated approval
    • Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals
    • Ensure completion of regulatory deliverables, according to agreed project timelines and development plans
    • Work with cross-functional team in different business units (clinical, CMC, commercial, etc) to formulate global regulatory plans and tactics
    • Lead compilation of regulatory dossier and ensure readiness for submission to health authorities
    • Manage global regulatory sub-team for specific projects composed of regulatory CMC, regulatory operations, regulatory intelligence and regulatory managers responsible for major markets


    The successful candidate should possess the following qualifications, experience and attributes…


    • University qualification in a relevant life science discipline; preferably with a higher academic qualification (PhD, PharmD)
    • Substantial experience gained in regulatory affairs and strategy 13+ years, via roles in the pharma/biotech industry, consultancy or regulatory health agencies
    • At least 10 years in regulatory development strategies, managing complex projects and FDA, EMA and other major agency consultations
    • Track record of regulatory approvals in oncology is a must, including hands-on experience across all phases of development and post-marketing
    • In-depth understanding of the current European and US regulations and the wider regulatory environment and trends – and their implications for the global drug development process
    • Knowledge of ICH, FDA and EMA guidelines and awareness of evolving regulatory environment
    • Established network and credibility with key customers including health authorities and industry


    Core Competencies


    • Strong sense of planning and prioritization, and the ability to work with all levels of management
    • Ability to influence and lead cross-functional team toward successful negotiation with agency
    • Ability to influence and interact effectively with internal and external customers
    • Ability to work effectively across functions in drug development and commercial organizations
    • Team player with good interpersonal skills
    • Strong oral and written communication skills
    • Good presentation, organization and planning skills
    • Able to undertake significant travel (approx. 30% a year)
    • Fluency in English, written and spoken - knowledge of other languages valuable



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