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 company's product development through clinical phases to market authorization.

We are seeking qualified individuals to join the team, which focus on supporting client's 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

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 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

About the Company

Aequor Technologies LLC