Regulatory Strategy Manager

Vertex Pharmaceuticals; London; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

A leading biotechnology company is seeking a Manager in Regulatory Affairs who will lead Clinical Trial Applications and support submissions to Competent Authorities. This position requires strong regulatory experience, excellent communication skills, and the ability to navigate complex regulatory environments, contributing to high-quality results within a creative team culture.

Qualifications

• Relevant industry experience in regulatory affairs.
• Bachelor’s or higher degree in life sciences.
• Must communicate fluently in English.

Responsibilities

• Lead Clinical Trial Applications and regulatory submissions.
• Be the key contact person with CROs on trials.
• Support RRLs on orphan and pediatric applications.

Skills

Regulatory Affairs Experience

Strategic Interpretation of Regulatory Requirements

Interpersonal Skills

Analytical Ability

Communication Skills

Education

Bachelor’s degree in life sciences

M.Sc. or Ph.D. degree

Job description

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• Reporting to the Senior Director Regulatory Affairs, the Manager (M) will lead and support Clinical Trial Applications (CTAs) to Competent Authorities as well as other regulatory submissions.
• The role will be a key contact with Clinical Research Organisations (CROs) and Health Authorities (HA)
  
  

Job Description

POSITION SUMMARY:

• Reporting to the Senior Director Regulatory Affairs, the Manager (M) will lead and support Clinical Trial Applications (CTAs) to Competent Authorities as well as other regulatory submissions.
• The role will be a key contact with Clinical Research Organisations (CROs) and Health Authorities (HA)
  
  

Key Responsibilities

Regulatory

• Work as Regulatory Regional Leads (RRL) on assigned clinical trials.
• Work close with GRLs and other RRLs on regulatory submissions including but not limited to: CTAs, substantial amendments, responses to Health Authority questions, DSUR submissions.
• Key contact person with CROs on assigned clinical trials
• Regulatory representative on cross functional Vertex teams to prepare submission activities from the planning phase through to submission.
• Support RRLs on regulatory procedures such as orphan and paediatric applications.
• Prepare timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date in RIM
• Work with local partners to provide local regulatory expertise, maintain current knowledge of regional requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner
• Become a regional expert for regulatory queries coming from other functions, e.g. clinical development and supply chain, on topics such as requirements and timelines for CTA-related submissions.
• Ensure all work is compliant with regulatory requirements and company policies and procedures
  
  

General

• As applicable, support and contribute to local cross-functional and leadership teams to achieve corporate and departmental goals and objectives.
• Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction
• Attend meetings at local or international Vertex Offices
• Exemplify Vertex’s core values in fulfilling these job duties
  
  

Education

• Bachelor’s degree in life sciences or M.Sc. or Ph.D. degree
  
  

Skills & Experience

Regulatory

• Relevant industry experience in regulatory affairs, including planning and executing CTA-related submissions
• Strategic experience in interpreting regulatory requirements for CTA-related submissions
• Understanding of current trends in regional requirements for clinical trial applications
• Recognized as a knowledgeable resource for regulatory advice by other departments
• Some experience of managing negotiations with Regulatory Authorities
• Must be able to facilitate interactions with International Regulatory Affairs, other departments within the company and external parties (mainly submission partners)
  
  

General

• Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
• Good interpersonal skills and ability to deal effectively with a variety of personalities
• 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
• Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.
• Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others.
• Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity
• Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.
• Ability to navigate and be successful in a fast-paced environment while delivering high quality results.
• Excellent communication skills, strong oral/written presentation skills.
• Fluent written and spoken English
  
  

EXPERTISE

Business and Management Expertise

• Experience in regulatory affairs with track record of success
• Experience in Clinical Trial Applications in multiple regions Specialized knowledge of local regulatory environments and stakeholders
  
  

DELIVERING SOLUTIONS

Problem Solving

• Proactively identify risks and develop potential solutions
  
  

IMPACT

Accountability

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

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• 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.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [e-mail]

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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