Location: Waterford

Job Type: Permanent, full time, hybrid

Hiring Manager: Virginie D'Agostino

Grade: Level 3

About the job

Within the GRA-CMC & Device department, the GRA-CMC Small Molecules Team manages the global regulatory CMC strategy for Sanofi's synthetic drugs portfolio, encompassing both development projects and marketed products. This team is a key partner to Manufacturing & Supply and CMC R&D, collaborating closely with other Global Regulatory Affairs (GRA) and local regulatory functions, as well as various stakeholders, including External Alliance Partners, Project Direction/Management (R&D Development, Pharma Operations teams), and Legal.

In this exciting role as the GRA-CMC Small Molecules Lead, you will work in an international environment, enhancing your knowledge of global regulations on synthetic drugs. You will coordinate cross-functional submission teams in both development and lifecycle management (LCM) spaces, and expand your professional network within GRA, Manufacturing & Supply, and CMC R&D.

• Represent GRA CMC Small Molecules in Global CMC and Global Regulatory Team(s) and meetings, partners with the leaders of these teams to facilitate successful product development and life cycle management; Facilitate together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, Health Authority (HA) meetings, etc.)
• Provide accurate regulatory assessments and expertise input to team recommendations, and communicate project plans, status and updates to management

• Develop, align and formulate the global regulatory CMC strategy and write strategy documentation (i.e. Change control assessments); manage changes in multiple international markets ensuring strategic approvals timings and supply continuity.
• Drive CMC regulatory risk assessments, and contingency planning and mitigation of identified regulatory risks

• 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

• 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

• 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

• 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

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

• Fluency in English language, both verbal and written

• 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.