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Open nowFirst seen 5 days ago

Associate Director, Regulatory CMC, Biologics

Lifelancer3,750 open roles

Pay
$166,400 – $249,600 a year
Where
Remote
Work mode
Remote
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Your applicationOpen nowAssociate Director, Regulatory CMC, BiologicsLifelancer · Remote

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  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Job Title: Associate Director, Regulatory CMC, Biologics

Job Location: 5000 - Vertex US - Fan Pier, United States of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job Description General Summary: The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities. The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review. Key Duties and 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 Serves as primary regulatory CMC lead for Health Authority interactions Provides regulatory guidance to cross-functional teams Leads regulatory assessment of CMC changes, deviations, and investigations Applies AI-enabled tools for authoring, review, and consistency checks Drives structured content and data traceability approaches Supports AI/digital capability development Contributes to process improvements and innovation initiatives Represents Regulatory CMC in governance forums Stays abreast of and adopts emerging technologies, including AI, and maintains a continuous learning mindset to strengthen regulatory CMC's decision-making and innovation. Proactively remains up to date on advances in technology, AI, automation, competitive intelligence, and changes in the regulatory environment. Knowledge and 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 Digital & AI-Enabled Regulatory Capabilities Working knowledge of AI tools for regulatory document preparation and review 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 Education and Experience: 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 leading CMC regulatory submissions and HA interactions for biologics Experience with complex or multi-product strategies preferred Pay Range: $166,400 - $249,600 Disclosure Statement: 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. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. 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] 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 pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

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