Title: Regulatory Affairs Specialist
Location : BRIDGEWATER, NJ - 08807
Type: 6 + Month Contract
Description:
Regulatory CMC Program Management Lead to support the Small Molecule Development (SMD) group. The SMD group is a key stakeholder in the GRA CMC&D organization to contribute to Sanofi pipeline success by ensuring regulatory approval for NMEs and NCEs to bring innovative medicines to patients. This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for small molecule development compounds.
Incumbent will be accountable to both the SMD group for communication and interpretation of new regulatory guidelines and Regulatory CMC managers for support of development projects.
Incumbent will provide support to Regulatory CMC managers in developing regulatory strategies on assigned projects, including but not limited to participating in CMC project team meetings and providing Regulatory CMC support, including providing strategies, follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application. Incumbent will lead strategic efforts, including but not limited to interpretation of new guidelines to ensure that new requirements and standards are properly implemented in the regulatory submission and analysis of queries from health authorities to identify trending deficiencies for improvement of CMC section to support clinical studies and marketing applications.
Years of Experience:
1 - 3 Years
Kindest Regards,
Ankush Lather
Talent Acquisition Specialist
Experis CORE+
100 Manpower Place | Milwaukee, WI 53212
Email ID:
Desk # - - Ext 7193