Director/Sr. Director, Regulatory CMC

Jobtailor; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor in Boston is seeking a Senior Regulatory CMC Leader to develop and implement global regulatory CMC strategies for gene therapy programs, lead submission activities, and act as the primary liaison with health authorities such as the FDA and EMA. You will guide cross-functional teams through complex regulatory interactions and ensure technical accuracy of CMC documentation.

The role requires 5+ years in regulatory CMC for ATMPs, strong leadership, and deep knowledge of ICH guidelines,

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 5+ years of expertise in regulatory CMC for gene therapy, cell therapy, or other ATMPs.
• 5+ years of experience with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA).
• In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (ICH, FDA, EMA).
• Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods.
• Proven leadership and interpersonal skills, with ability to influence and collaborate with cross-functional teams and external stakeholders.
• Ability to manage multiple projects in a fast-paced environment.
• Proficiency in regulatory information management systems and Microsoft Office Suite.

Responsibilities

• Develop and implement global regulatory CMC strategies for gene therapy programs.
• Lead and manage preparation, authoring, and review of CMC sections for regulatory submissions.
• Act as primary regulatory CMC liaison with health authorities (FDA, EMA, PMDA).
• Provide expert regulatory CMC guidance to cross-functional development teams.
• Identify and assess regulatory CMC risks and opportunities; develop mitigation strategies.
• Stay current with evolving global regulatory requirements for gene therapies and ATMPs.
• Lead and mentor junior regulatory CMC professionals.
• Contribute to development and improvement of internal regulatory CMC processes and templates.
• Manage external consultants and contractors as needed.

Skills

Regulatory CMC Strategy

IND/CTA Submissions

BLA/MAA Submissions

Global Regulatory Submissions

Gene Therapy Knowledge

Leadership Skills

Regulatory Information Management

Cross-Functional Collaboration

Microsoft Office

Education

Bachelor's degree in a scientific discipline

Job description

• Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions
• Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines
• Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings
• Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle
• Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership
• Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs)
• Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement
• Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates
• Manage external consultants and contractors as needed to support regulatory CMC activities

Requirements

• Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required
• 5+ years of expertise in regulatory CMC for gene therapy, cell therapy, or other advanced therapeutic medicinal products (ATMPs)
• 5+ years of experience with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.)
• In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA)
• Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods
• Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders
• Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment
• Proficiency in regulatory information management systems and Microsoft Office Suite.

Core Competencies

Expertise in developing and implementing global regulatory CMC strategies for gene therapy programs, with a strong focus on regulatory submissions and compliance. Proven ability to lead cross-functional teams and mentor junior professionals while managing regulatory risks and opportunities.

Highest-signal resume keywords

• Regulatory CMC Expertise
• Global Regulatory Submissions
• Gene Therapy Knowledge
• Leadership Skills
• Regulatory Information Management

ATS Optimization Keywords

Hard Skills

• Regulatory CMC Strategy Development
• IND/CTA Submission
• BLA/MAA Submission
• Regulatory Guidelines Adherence
• Scientific Accuracy in Documentation
• Analytical Methods Understanding
• Manufacturing Process Knowledge
• Risk Assessment and Mitigation
• Cross-Functional Team Collaboration
• Continuous Improvement Processes

Soft Skills

• Interpersonal Skills
• Influencing Skills
• Project Management
• Mentoring Skills
• Collaboration Skills

Industry Keywords

• Gene Therapy
• Advanced Therapeutic Medicinal Products (ATMPs)
• Biologics
• FDA
• EMA
• ICH
• Health Authorities
• Regulatory Submissions
• Post-Approval Submissions
• Cross-Functional Development Teams

Tools & Technologies

• Regulatory Information Management Systems
• Microsoft Office Suite