R&D - Director, RA CMC - SH

Job description

Provide support for the CMC activities for Vaccines Portfolio in China by:

·  Evaluating impacts and making risk analysis of CMC life cycle activities for both local and imported products.
·  Supporting or leading China saucerization plan (CSP)
·  Supporting new vaccine registration
·  Running regulatory intelligence for any new regulation related to CMC topics.

1. LCM management

·  For imported vaccines: confirm the reporting level of new CCRs; Leading or support activities related to high-risk changes & liaise with PFP for dossier authoring and CCRs monitoring.

2. Supporting on new registrations

·  Develops China regulatory CMC strategies and risk assessments for new registration in collaboration with Global GRA CMC, global CMC and RA local affiliate team.
·  Support or directly contribute to the preparation, review and approval of regulatory CMC dossiers for submissions in China, in collaboration with GRA CMC, global CMC and RA local affiliate team. Assures that submission dossiers meet appropriate quality standards.

3. Support Health Authority interactions for topics related to vaccines imported in China:

·  Support GRA CMC Product Focal Points and local GRA teams in preparation of HA meetings.
·  Represent GRA CMC at HA meetings in China supporting discussion of CMC / manufacturing related topics.

4. Support advocacy activities

·  Contributes knowledge and expertise on the GRA CMC&D China Focus Group, GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, e.g., the RDPAC CMC taskforces, in order to assure that appropriate Sanofi visibility and input is recognized.  Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers.  Assures that current Health Authority thinking, and trends (paradigm shifts) are understood and broadly communicated. 

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.