Vertex Pharmaceuticals

Vertex Pharmaceuticals

Associate Director, Regulatory CMC, Biologics

Boston, MA · Director

Sponsorship not specified$166k-$250kDetected 13 hours ago
RecruitingFDA RegulatoryLeadershipCommunicationProblem SolvingRegulatory Affairs

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
  • Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1.

Responsibilities

  • Leads preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)
  • Develops and drives global CMC regulatory strategies for assigned programs
  • Leads regulatory assessment of CMC changes, deviations, and investigations
  • Drives structured content and data traceability approaches
  • Supports AI/digital capability development
  • The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics.
  • The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review.

Requirements

  • Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred)
  • 8+ years of experience in pharmaceutical or biotechnology industry with a focus on biologics
  • Experience with complex or multi-product strategies preferred

Skills

  • Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologics
  • Strategic thinking and problem solving
  • Excellent communication skills
  • Ability to lead and influence cross-functional teams
  • Strong planning and prioritization skills
  • Ability to work in a global matrixed environment
  • Commitment to quality and compliance
  • May include people management responsibilities
  • Experience with structured content and data-driven authoring
  • Ability to critically review AI-assisted outputs
  • Familiarity with digital submission and data integrity expectations
  • Ability to identify automation and AI opportunities

Compensation

  • $166,400 - $249,600
  • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.
  • This role is eligible for an annual bonus and annual equity awards.
  • Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Benefits

  • Serves as primary regulatory CMC lead for Health Authority interactions
  • Stays abreast of and adopts emerging technologies, including AI, and maintains a continuous learning mindset to strengthen regulatory CMC's decision-making and innovation.

Company info

  • work remotely up to two days per week; or select
  • work five days per week on-site with ad hoc flexibility.
  • 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 ApplicationAssistance@vrtx.com
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This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.