CMC Dossier Leader AI transformation Champion

About the Job
The CMC Dossier Sciences department within client R&D Global CMC Development organization has
critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to
enable advancement of companys product development through clinical phases to market authorization.
We are seeking qualified individuals to join the team which focus on supporting clients innovative
pipeline of Mammalian products.

Main Responsibilities:
Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory
documents
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

Experience:
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

Soft and technical skills:
Agility to embrace digital transformation and AI/ML applications
Knowledge of at least one aspect of CMC development for Biologics: Cell line
development Formulation DS/DP aseptic 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
Agencys 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 leveraging with digital tools (e.g. Vault RIM Word and adobe)

Education:
MS or PHD or an equivalent level degree in life sciences in one of the areas of
biopharmaceutical drug development (e.g. pharmaceutical chemistry pharmacy biology
biotechnology biochemistry or related degree)
In depth and superior knowledge in pharmaceutical development is mandatory

Languages:
Excellent oral and written English communication skills

Experience (nice to haves):
Experience working with agile/scrum methodologies in pharmaceutical development
CMC knowledge and experience in Cell/Gene Therapeutics
Experience with data integration platforms
Soft and technical skills:
Understanding of AI/ML applications in pharmaceutical development
Knowledge of digital quality management systems and electronic batch records