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Join to apply for the Regulatory Strategy Associate Director role at Vertex Pharmaceuticals

• The Regulatory Affairs (RA) Associate Director (AD) participates in the development and implementation of regulatory strategy for specific programmes
• This individual will be responsible for planning and coordinating complex regulatory submissions, e.g., MAAs and new therapeutic indications, and will also represent RA on multidisciplinary sub-teams.
  
  

• The Regulatory Affairs (RA) Associate Director (AD) participates in the development and implementation of regulatory strategy for specific programmes
• This individual will be responsible for planning and coordinating complex regulatory submissions, e.g., MAAs and new therapeutic indications, and will also represent RA on multidisciplinary sub-teams.
  
  

• Act as the Regional Regulatory Lead (RRL) for assigned products
• In collaboration with Global Regulatory Lead (GRL), develop regulatory strategy for assigned projects
• 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
• Manage the preparation and submission of technically complex regulatory submissions, with minimal supervision, for assigned products in line with regional regulatory requirements
• Provide appropriate strategic regulatory advice to Submission and Project Teams in a timely manner
• Keep regulatory affairs senior management informed on the status of global strategies and tactics, procedures and practices, with a focus on regulatory and policy trends in the EU
• Act as primary Company contact with Regulatory Authorities for assigned products and territories
• Maintain knowledge of regulatory requirements and anticipate, assess and communicate changes in regulatory information to project teams and senior management in a timely manner
• Lead local and/or global company process improvement initiatives
• Ensure all work is compliant with regulatory requirements and company policies and procedures
  
  

• Work with cross-department teams (e.g. Global Regulatory Subteams) and key IHQ functions to achieve corporate and departmental goals and objectives.
• Ability to travel to corporate headquarters as well as attend EU meetings as required
• Exhibit ownership and accountability for all projects and internal assignments;
• Able to plan, schedule and arrange own work activities with limited direction
• Exemplify Vertex’s core values in fulfilling these job duties
  
  

• Bachelor’s degree in life sciences required
  
  

• Recent direct experience of clinical development is essential
• Leading direct interactions with a variety of stakeholders including EMA, and national Competent Authorities on clinical development and complex regulatory submissions
• Experience of leading complex regulatory submissions such as MAAs, new indications, and PIPs
• In-depth knowledge of regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends
• Recognized as a knowledgeable resource for regulatory advice in other departments
  
  

• 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
• 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
  
  

• Experience in regulatory affairs with track record of success for complex regulatory submissions
• Experience across the life-cycle (development, MAA, post-authorization)
• Specialized knowledge of regulatory environments and respective stakeholders (e.g., EMA, Swissmedic, TGA, etc.).
  
  

• Proactively identify risks and develop potential solutions
  
  

• Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans
  
  

• Responsible for complex regulatory submission of key impact to the business (e.g., MAAs and new therapeutic indications)
  
  

• Anticipate submission activities to permit accurate budgeting and forecasting
  
  

• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.
  
  

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Business Development and Sales

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