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Regulatory Strategy, Senior Manager

Semma Therapeutics

Semma Therapeutics

Legal
Paddington, London W2, UK
Posted on Friday, May 31, 2024

Job Description

SUMMARY:

The Senior Manager Regulatory Strategy (UK&IE) supporting the UK/IE affiliate, will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices.

The Regulatory Strategy Senior Manager will support the Regional Regulatory Lead for the UK.

This role requires understanding of the regulatory affairs framework in the UK and EU.

KEY RESPONSIBILITIES:

  • Act as contact with MHRA for regulatory activities
  • Manages the process for preparation, submission, and approval of regulatory applications in the UK
  • Be part of regulatory interactions with the health authority in collaboration with the Regional Regulatory Lead for the UK.
  • Provides strategic guidance to teams on regulatory requirements for submissions in the UK
  • Provides local regulatory expertise, maintains current knowledge of local requirements and anticipates, assesses and communicates changes to local and RA Senior Management in a timely manner
  • Act as local UK expert for regulatory queries coming from other functions, e.g. medical, commercial, market access, quality and supply chain
  • Review and approval of mock-ups, commercial artwork and product information
  • Review of promotional material according to the local MHRA blue guide and ABPI code
  • Working with cross functional team for review, submission and approval of commercial materials as part of the pre-vetting process with the MHRA
  • Participate in local cross-functional launch activities
  • Local inspection and audit support
  • Ensure all work is compliant with regulatory requirements and company policies and procedures

EDUCATION:

Bachelor’s degree in life sciences required

SKILLS AND EXPERIENCE:

  • Extensive experience in pharmaceutical or biotech industry within regulatory affairs in the UK.
  • Experience across the life-cycle (development and post-authorization).
  • Specialized knowledge of MHRA regulatory environment and stakeholders
  • Good understanding of drug development process and requirements to maintain a product on the market; reporting and surveillance
  • Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment
  • Strong problem-solving skills
  • Strong written and verbal communication skills to explain difficult information and build alignment
  • Ability to work effectively within a team environment
  • Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner

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 ApplicationAssistance@vrtx.com.