Jobs › Companies › Vertex Pharmaceuticals › Regulatory Strategy Manager

Über diese Regulatory Strategy Manager Stelle bei Vertex Pharmaceuticals

Vertex Pharmaceuticals · Hybrid · Paddington, United Kingdom

Job Description

General Summary:

The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in the US, Europe, or other international markets, and understanding of drug development and related concepts.

Key Duties and Responsibilities:

  • Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team
  • Contributes to and may lead global regulatory strategy development for certain programs
  • Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority
  • Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathways
  • Manages the process for preparation, submission, and approval of regulatory applications within assigned region
  • Provides strategic and technical regulatory input for key product development or registration documents
  • Ensures compliance of regulatory submissions with current regulations and guidance
  • Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region
  • Knowledge and Skills:

  • In-depth knowledge of global and regional regulatory affairs frameworks
  • Good understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
  • Good understanding of requirements and processes 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
  • Education and Experience:

  • Bachelor's degree in Biology, Chemistry, or other related discipline
  • Typically requires 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience

  • At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

    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.


    #LI-Hybrid  

    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 [email protected]

    Bereit, sich bei Vertex Pharmaceuticals zu bewerben?
    Bei Vertex Pharmaceuticals bewerben

    Über Vertex Pharmaceuticals

    Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic

    Alle Jobs bei Vertex Pharmaceuticals ansehen →

    Ähnliche Jobs

    42dot
    [집중채용] Senior Strategy Manager
    42dot
    ⚡ Früh bewerben Pangyo (Software Dream Center)... Hybrid
    ● Neu 👁 Gesehen ✓ Beworben vor 3 Std.
    Appzen
    Senior GTM Strategy and Analytics Manager
    Appzen
    ⚡ Früh bewerben Santa Clara, California Vor Ort
    ● Neu 👁 Gesehen ✓ Beworben vor 3 Std.
    Samsara
    Sr. Regional Web Strategy Manager
    Samsara
    ⚡ Früh bewerben Remote - Chicago Hybrid $131,963–$155,250
    ● Neu 👁 Gesehen ✓ Beworben vor 6 Std.
    Cloudflare
    Interconnection Manager, Network Strategy Americas
    Cloudflare
    ⚡ Früh bewerben Hybrid Hybrid $150,000–$207,000
    ● Neu 👁 Gesehen ✓ Beworben vor 6 Std.
    Datavant
    Strategy & Operations Analyst
    Datavant
    ⚡ Früh bewerben Remote - United States · standortgebunden $104,000–$130,000
    ● Neu 👁 Gesehen ✓ Beworben vor 7 Std.
    Wolt - English
    Consumer Growth Strategy Manager, EMEA
    Wolt - English
    ⚡ Früh bewerben Berlin, Germany; Frankfurt am... Vor Ort
    ● Neu 👁 Gesehen ✓ Beworben vor 8 Std.
    Tabs
    Senior Manager, GTM Strategy & Operations
    Tabs
    ⚡ Früh bewerben New York City, NY Vor Ort $150,000–$215,000
    ● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
    MongoDB
    Manager, Sales Strategy & Planning
    MongoDB
    ⚡ Früh bewerben Los Angeles; San Francisco Vor Ort $98,000–$193,000
    ● Neu 👁 Gesehen ✓ Beworben vor 9 Std.
    Crunchyroll, LLC
    Membership Strategy Senior Manager
    Crunchyroll, LLC
    ⚡ Früh bewerben Los Angeles, California, Unite... Hybrid $145,100–$180,000
    ● Neu 👁 Gesehen ✓ Beworben vor 10 Std.

    Registrieren für Vorschläge, die auf die von Ihnen geöffneten Jobs und gespeicherten Suchen zugeschnitten sind.

    Mehr Jobs bei Vertex Pharmaceuticals

    Alle Jobs bei Vertex Pharmaceuticals ansehen →

    Jetzt bewerben
    🤖

    Moment — langsam

    JobsRadar wurde für echte Menschen gebaut, die eine schwere Zeit bei der Jobsuche haben — nicht für automatisierte Anfragen. Sie klicken viel zu schnell und sind jetzt vorübergehend blockiert.

    Kommen Sie später wieder. Wenn Sie wirklich auf Jobsuche sind, stehen wir hinter Ihnen — verhalten Sie sich einfach wie ein Mensch.

    Catch your next role the second it’s posted.

    Create a free account and we’ll watch the boards for you — the instant a job matches your search, it lands in your inbox or Telegram. No digging, no refreshing.

    Create free account

    Free forever · takes 30 seconds · already have one?

    Verschaffe dir einen Vorsprung bei der Jobsuche.

    Tritt unserem Telegram-Kanal bei für das, was dir hilft, die Stelle zu bekommen — Gehaltsbenchmarks, den wöchentlichen Marktpuls und neue Feature-Drops. Kein Spam, nur Signal.

    Dem Kanal beitreten — kostenlos