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Open nowFirst seen 4 days ago

Director, Regulatory Affairs CMC

Lifelancer3,738 open roles

Pay
$190,400 – $285,600 a year
Where
Remote
Work mode
Remote
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Your applicationOpen nowDirector, Regulatory Affairs CMCLifelancer · Remote

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This job: first seen 4 days ago

The posting

Job Title: Director, Regulatory Affairs CMC

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 Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans. The Director drives organizational excellence through talent development, process innovation, and the application of digital and AI-enabled capabilities to enhance the quality, consistency, and efficiency of regulatory decision-making, document preparation, and submission execution. Key Duties and Responsibilities: Leads development and execution of global CMC regulatory strategies for multiple investigational and marketed products in the small molecule portfolio. Oversees preparation, review, and approval of CMC content for global regulatory submissions. Provides strategic leadership for Health Authority interactions and negotiations. Leads and develops Regulatory CMC staff through coaching and talent development. Ensures consistent regulatory guidance to cross-functional stakeholders. Serves as senior Regulatory CMC representative on governance bodies and product teams. Identifies regulatory risks and develops mitigation strategies. Drives continuous improvement through structured content and digital regulatory capabilities. Champions AI-enabled technologies for authoring, review, data traceability, and knowledge management. Ensures programs are appropriately resourced and accountable for regulatory milestones. 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: Comprehensive knowledge of FDA, EMA, Health Canada, ICH, and global CMC requirements. Advanced strategic thinking and regulatory risk assessment skills. Exceptional communication, negotiation, and leadership skills. Ability to influence senior leaders and governance committees. Strong organizational and resource planning capabilities. Proven ability to build and develop high-performing teams. Knowledge of digital regulatory trends, structured content, data governance, and AI applications. Ability to establish governance and controls for AI-enabled regulatory processes. Experience leveraging AI-enabled tools for dossier preparation, content development, review, and knowledge management. Ability to evaluate and oversee AI-generated regulatory content. Experience implementing technology-enabled process improvements in regulated environments preferred. Education and Experience: Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or related life sciences discipline. Advanced degree (M.S., Pharm.D., or Ph.D.) preferred. 10+ years of pharmaceutical, biotechnology, or related industry experience supporting small molecule development. 3+ years of people management experience leading technical and/or regulatory professionals. Experience developing and executing global CMC regulatory strategies. Experience leading major submissions and Health Authority interactions. Experience driving organizational change and process improvements. Demonstrated leadership in global matrix organizations. May have budgetary and direct people-management accountability. Commitment to innovation, continuous improvement, and operational excellence. *LI-EE1 *LI-Hybrid Pay Range: $190,400 - $285,600 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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