Job title: CMC dossier leader

• Location: Framingham, MA

Main responsibilities:

• Lead, coordinate, and manage CMC dossier preparation and development processes.

• Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients.

• Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers.

• Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from Health Authorities).

• Ensure consistent information presented throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between CMC dossiers.

• Contribute to the elaboration/improvement of the submission templates and authoring guides in close collaboration with CMC functions, GRA CMC and Digital teams.

• Support M&A, in licensing due diligence activities by assessing the CMC dossiers content.

• Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents.

About you

• PhD, MS, other university degrees in one of the areas of pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).

• In depth and superior knowledge in pharmaceutical development is mandatory.

• Minimum 5 years of professional experience in CMC development.

• Proven track record in authoring CMC dossiers.

• Understanding of current pharmaceutical environment including digital transformation, economic and regulatory challenges.

• Agility to embrace digital transformation and AI/ML applications.

• Knowledge of at least one aspect of CMC development for synthetics: Chemistry, Drug product development (formulation & manufacturing), Analytical development, and Process and Method validations.

• Comfortable working in digital-first environments with ability to quickly adopt new technologies.

• Understanding of regulatory documents required to support product development milestones, consultation meetings with agency, site inspections, or written responses to Agency’s information requests.

• Knowledge of CMC dossier structures required for clinical trial and market authorization submissions.

• Leadership capabilities: Ability to lead cross-functional teams with internal and/or external partners.

• Strong team spirit with assertiveness: ability to represent CMC Dossier Sciences and contribute to cross-company projects.

• Facilitator skill to resolve issues and move project forward.

• Agility in priorities, readiness to adopt a TRT culture and embrace continuous digital innovation.

• Proficiency in Vault RIM, Word and Adobe.

Skills that you could improve in this new position (to develop)
 

• Advanced expertise in AI-powered tools for document intelligence and automation

• Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs 

• AI applications and prompt engineering

• Core Competencies: Strategic planning, time management, and communication, digital transformation leadership within CMC community, innovative problem-solving for CMC dossier challenges, change management and process optimization.

Skills that you could offer in addition (nice to have)

• Experience working with agile/scrum methodologies in pharmaceutical development.

• Experience with data integration platforms.

• Understanding of AI/ML applications in pharmaceutical development.

• Knowledge of digital quality management systems and electronic batch records.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.