GRA - CMC - Small Molecules Lead

About the job

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?

Our Team:

Within the GRA-CMC & Device department, the GRA-CMC Small Molecules Team manages the global regulatory CMC strategy of sanofi’s synthetic drugs portfolio (development projects and marketed products). As such, this team is acting as a major partner of Manufacturing & Supply and CMC R&D, collaborating closely with other Global Regulatory Affairs (GRA) and local regulatory functions, and with many various stakeholders (External Alliance Partners, Project Direction/Management (R&D Development, Pharma Operations teams), Legal).

Main responsibilities:

• Act as the GRA CMC Small Molecules representative in project / product teams

  • Represent GRA CMC SmallMolecules in Global CMC and Global Regulatory Team(s) and meetings, partnerswiththeleaders of theseteamstofacilitatesuccessfulproductdevelopment and life cycle management; Facilitatetogetherwiththe CMC teams and regional/local regulatoryexpertstheplanning and execution of regulatoryactions (submissions, Health Authority (HA) meetings, etc.)

  • Provideaccurateregulatoryassessments and expertise input to team recommendations, and communicate project plans, status and updatesto management

  Develop and execute global regulatory CMC strategy for assigned product(s)

  • Develop, align and formulatetheglobalregulatory CMC strategy and writestrategydocumentation (i.e. Changecontrolassessments); managechanges in multipleinternationalmarketsensuringstrategicapprovalstimings and supplycontinuity.

  • Drive CMC regulatoryriskassessments, and contingencyplanning and mitigation of identifiedregulatoryrisks

  Manage global regulatory submissions and dispatches of CMC packages for new applications / maintenance, amendments, variations and supplements, response submissions etc.

  • Plan submissions and CMC dossier/package strategies per the product’s global CMC regulatory strategy for CTA/INDs, MAAs, international MAs, HA meetings, maintenance submissions, change amendments/supplements, commitments, etc.

  • Manage regulatory databases for planning and tracking of regulatory submissions; coordinate and support dossier preparation, review and publishing process in line with project timelines

  Manage CMC related Health Authority liaison and communication

  • Interact and liaise directly with FDA, EMA on product and CMC topics, coordinates HA interactions on CMC topics with other health authorities including international with local/regional teams

  • Lead the Regulatory CMC content of meetings with FDA, EMA, supports HA meetings as SME in international countries; communicate outcomes of HA procedures or feedback to teams and management, track HA communication and questions/responses in regulatory databases

  About you 

  Experience:

  • Proven experience gained in regulated pharmaceutical environments (research, development, manufacturing, or analytics), with at least part of it in a formal regulatory CMC position.

  • Established expertise with assessing CMC source documentation/reviewing CMC dossier documents, managing regulatory procedures and HA interactions

  • Experience with continuous CMC dossier optimization

  • Experience with coordination of cross functional projects, in an international, matrixed, fast-paced environment

  Soft and Technical skills:

  • Knowledge of global regulations/guidelines

  • Proficient in using Veeva Vault RM and other digital tools (MS Word, Excel, PowerPoint, regulatory databases and document management systems), ability to trouble shoot or help put in place continuous improvements in Veeva

  • Organizational and communication (written and verbal) skills

  • End to end thinking, big picture in mind of what the end goals are for customers, Sanofi as a whole

  • Project management skills

  • Patient- and quality-focused mindset and able to drive a culture of continuous improvement 

  • Proactivity

  Education:

  • Minimum of a Bachelor’s Degree; in a science/health field (eg, Regulatory, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent

  Languages:

  •  Fluency in English language, both verbal and written

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.

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