CMC Dossiers Leader
Company: Sanofi
Location: Framingham
Posted on: April 25, 2025
Job Description:
Job Title: CMC Dossiers Leader
Location: Framingham, MA
About the Job
Are you ready to shape the future of medicine? The race is on to
speed up drug discovery and development to find answers for
patients and their families. Your skills could be critical in
helping our teams accelerate progress.
The CMC Dossier Sciences department within Sanofi 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 our US teams, which focus on
supporting Sanofi's innovative pipeline of Mammalian and Gene
Therapy products.
The CMC Dossiers Leader will lead, coordinate, and manage CMC
dossier development processes and serves as the central contact
point of a CMC sub team (Dossier Subgroup or Submission Taskforce)
for authoring, review, comment resolution, and document control to
ensure timely delivery of CMC dossier for regulatory submissions
(IND/IMPD /CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from
Health Authorities). In the digital environment, the CMC dossiers
leader will actively contribute to the reshaping of the Submission
documentation in close collaboration with CMC functions and GRA
CMC.
We are an innovative global healthcare company with one purpose: to
chase the miracles of science to improve people's lives. We're also
a company where you can flourish and grow your career, with
countless opportunities to explore, make connections with people,
and stretch the limits of what you thought was possible. Ready to
get started?
Main Responsibilities
- As a core member of the CMC project team and in close
collaboration with Regulatory CMC, he/she develops dossier
strategies to enable parallel development of CMC dossiers with CMC
activities to force fast-to-clinic/fast-to-patients objectives.
- Lead a dossier sub team comprising of SMEs from various CMC
functions for dossier preparation. Provide authoring guidance,
templates, regulatory storyline, tools, and way of working and
resolve obstacles as they arise.
- Lead authoring process, conduct team/management reviews, and
facilitate resolutions to comments to ensure delivery of
high-quality CMC dossier that is in alignment with project
objectives and timelines.
- Ensure consistent information presented throughout CMC dossiers
and with other modules (e.g. clinical and preclinical) and between
CMC dossiers
- Prepare/write CMC summaries (e.g., Quality Overall Summary),
introductions, reviewer guides, and regulatory documents (e.g.
Investigator Brochure and Briefing Package) based on available CMC
data.
- Prepare and approve in Vault RIM the CMC sign-off sheet with
the approved CMC documents and handover to GRA CMC for
publishing.
- Share lessons learned across the organization and provide state
of the art guidance for dossier requirements.
- Lead dossier activities with external partners and CDMOs.
- Support M&A, in licensing due diligence activities by
assessing the CMC dossiers content.
- Review and/or approve CMC dossiers and act as CMC Dossier
modality head delegate.
- Guide and train new CMC Dossier Leaders and manage apprentices
or trainees, GIGs & CMC helping hands.
- Contribute to future digitalization & AI solutions in
regulatory environment e.g.: digital dossier solutions for
supporting future submission paradigm (ICH M4Q R2: revision of CTD
M2 & M3 Quality section, augmented authoring initiatives)
About You
Basic Qualifications
- PhD, MS, other university degrees in one of the areas of
biopharmaceutical drug development (e.g. pharmaceutical chemistry,
pharmacy, biology, biotechnology, biochemistry). In depth and
superior knowledge in pharmaceutical development is mandatory. 5-10
years professional experience ideally in CMC development is
required.
- Proven records of leading CMC dossier development for clinical
trial application or market registration submission (i.e.,
BLA/MAA/NDA)
Required Knowledge and Skills:
- Knowledge of at least one aspect of CMC development for
Biologics and/or Synthetics: Chemistry, Cell line development,
Formulation, DS/DP aseptic manufacturing, Analytical development,
and Process and Method validations.
- Experiences in writing of CMC dossiers sections - Knowledge of
CMC dossier structures required for clinical trial and market
authorization submissions.
- Understanding of regulatory documents required to support
product development milestones, consultation meetings with agency,
site inspections, or written responses to Agency's information
requests.
- 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.
- Experience and understanding of current pharmaceutical
environment including the economic and regulatory challenges.
- Ability to anticipate, prevent and resolve CMC dossier
challenges by thinking out of the box.
- Excellent oral and written English communication skills.
- Facilitator skill to resolve issues and move project
forward.
- Organization skill for planning, time management, and
communication.
- Agility in priorities; readiness to adopt a TRT (thoughtful
risk taking) culture.
- Experienced in working with digital tools (e.g.: Vault RIM,
Word and Acrobat)
- Interest in new digital approaches and appetency for new
digital software. Experienced in working with an agile
methodology.
- Constantly question and challenge status-quo and propose new
ways of working, especially with a focus of digitalization
Optional Skills:
CMC knowledge and experience in Cell/Gene Therapeutics is a
plus.
POTENTIAL CAREER EVOLUTIONS FOR JOB INCUMBENT
- Larger responsibilities within CMC dossiers
- CMC Project leader or manager
- GRA-CMC
- Quality manager
- Other potential opportunities within the CMC field or
Regulatory or Digital transformation
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and
Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.
#GD-SA
#LI-SA
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#vhd
All compensation will be determined commensurate with demonstrated
experience. Employees may be eligible to participate in Company
employee benefit programs, and additional benefits information can
be found here.PandoLogic. Keywords: General Labor, Location:
Framingham, MA - 01705 , PL: 597305715
Keywords: Sanofi, Pittsfield , CMC Dossiers Leader, Other , Framingham, Massachusetts
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