Senior Director, Regulatory Strategy, ROW

The Regulatory Affairs (RA) Senior Director Rest of World (ROW) is responsible for regulatory strategy and execution of submissions in the ROW region, including the planning and coordinating of complex regulatory submissions, e.g., MAAs and new therapeutic indications, and will also represent RA on multidisciplinary teams. ROW is defined as the Vertex International region outside of Europe (EU, UK and CH)., Regulatory

• Acts as the Regulatory ROW Lead managing International ROW regulatory team, which includes ROW submission team at IHQ and affiliate teams in the ROW region
• Primary accountability for working with regulatory consultants and distributor partners in the ROW region
• Works with team to define submission strategies and tactics for the ROW region
• In collaboration with Intl Reg leads and Global Regulatory Therapy Area Lead (GRTAL), defining ROW regulatory strategy for products within assigned therapy area and leading or contributing to regulatory and policy discussions with a broad range of global and cross-functional stakeholders.
• Providing strong strategic and tactical ROW regulatory contributions to Global development plans for assigned drug candidate/s, in addition to other selected development projects.
• Being the primary contact for ROW Regulatory Affairs with the Vertex International business and business partners / distributors
• Effectively working with a cross department team (i.e. Regulatory Policy, Regulatory CMC, Regulatory Operations, Advertising, Labelling & Promotions, etc.) leaders to achieve corporate business and departmental goals and objectives.
• Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, with any identified risks (from emerging data, changing internal objectives or external threats) communicated to RA Senior Management in a timely manner
• Anticipating global regulatory changes in the ROW region and developing a proactive strategy accordingly.
• Counselling and advising senior management on the status of ROW Regulatory Affairs strategies and tactics, procedures and practices, with a focus on regulatory and policy trends
• Working to influence regulatory environment through active participation in conferences, industry / agency regulatory committees and trade associations.
• Member of the International Regulatory Affairs Leadership Team
• May act as Regulatory Regional Lead or Global Regulatory Lead for one or more products
General
• Work with cross-department teams (e.g. submission teams and launch teams), key IHQ functions and business partners and distributors to achieve corporate and departmental goals and objectives.
• Supervising, coaching and mentoring junior staff, as well as peers; providing training, sharing insights and promoting an environment of continuous learning and improvement within department.
• Helping cross-functional process improvement efforts - for example aligning on new & more efficient ways of working, mapping processes, creating new business documents (e.g. new SOPs).
• Exhibit ownership and accountability for all projects and internal assignments
• Ability to travel to US as well as attend ROW meetings as required
• Exemplify Vertex's core values in fulfilling these job duties
Knowledge and Skills: Regulatory
• Recent direct experience of regulatory submissions and maintenance of approvals across multiple therapeutic areas and product modalities. Must include leading direct interactions with a variety of stakeholders including consultants, partners/distributors and ROW national Authorities.
• Extensive experience of defining and executing ROW Regulatory strategy
• Ability to apply Regulatory knowledge with a broad global and cross-functional mindset essential
• Recognized as a knowledgeable resource for regulatory advice in other departments, Accountability - ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans
• Strategic Planning - responsible for the development of regulatory strategies, or complex regulatory submissions of key impact to the business (e.g., MAAs and new indications)
• Adaptability - comfortable in a robust, challenging, rapidly evolving and growing company environment
• Financial Management - Anticipate submission activities to permit accurate budgeting and forecasting
  
  Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
• Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct
• Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements
• Ability to navigate and be successful in a fast-paced environment while delivering high quality results
• Adaptable to changing plans when situations require it and able to maintain composure and make decisions in uncertain circumstances
• Able to behave independently with minimal guidance where needed, but must understand and embrace being part of a team and working collaboratively with others within the function and cross-functionally
• Direct line management experience and demonstrated ability in coaching and mentoring more junior staff and peers in a matrix environment is essential.
• Good interpersonal skills and ability to deal effectively with a variety of personalities
• Empowers other team members through delegation of tasks and decisions
• Excellent communication skills, strong oral/written presentation skills.
• Acts to promote an energizing, inclusive environment and good morale
• Fluent written and spoken English, Problem solving - proactively identifies risks and develop potential solutions, Bachelor's degree in life sciences required; Masters-level or Ph.D. degree is preferred
• Typically requires significant years of relevant pharmaceutical or biotech industry experience within regulatory affairs, and extensive experience of supervisory/management experience, or the equivalent combination of education and experience
• Experience in regulatory affairs with track record of success for complex regulatory submissions
• Specialized knowledge of regulatory environments and respective stakeholders (e.g., ROW Regulatory agencies).
#LI-SG1 #LI-Hybrid Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.