CMC Dossier Leader - AI transformation Champion
Aequor JD ·www.aequor.com
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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
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
Frequently asked questions
Who is hiring for the CMC Dossier Leader - AI transformation Champion role?
Aequor JD is hiring for the CMC Dossier Leader - AI transformation Champion position, a Shazamme client. Apply directly on the employer's career site.
Where is the CMC Dossier Leader - AI transformation Champion job located?
The CMC Dossier Leader - AI transformation Champion role with Aequor JD is based in Piscataway, NJ, US.
Is the CMC Dossier Leader - AI transformation Champion role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the CMC Dossier Leader - AI transformation Champion role?
The CMC Dossier Leader - AI transformation Champion position is aimed at mid-level candidates.
How do I apply for the CMC Dossier Leader - AI transformation Champion role at Aequor JD?
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