Senior Research Investigator

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.Job Summary:
Within Chemistry, Manufacturing and Control (CMC), the CMC Dossier Coordinator coordinates preparation, review, and approval of regulatory CMC dossiers (Investigator's Brochure, IMPD, IND, CTD, amendments, responses, and briefing packages) for global clinical trials and/or market registrations. Ensures scientific consistency, checks global regulatory compliance and ensures timely availability of CMC documentation coming from Analytical Sciences Department, Pharmaceutical Sciences Department, Chemical Development Department and Industrial Affairs, and third-party collaborations as applicable. Provides a departmental regulatory support to the authors of submission documents in CMC, based on business requirements and on a high technical experience. Compiles the CMC dossier and writes the technical/scientific storyline. Prepares or coordinate the preparation of the quality overall summaries for CTD submissions. Reports and communicates on project CMC activities to line management. Participates to the CMC Coordination Team. Co-coordinate with DARG-RCMC the CMC Dossier Sub-group. Proposes improvements to the submission documentation management systems and processes.Duties & Responsibilities:
PROJECT COORDINATION
To coordinate review, comment, compile, and publish (to be discussed), and hand over of the approved CMC dossiers for Clinical trials requests and Marketing Authorization Application including responses to questions raised by agencies
To define the lifecycle for each CMC dossier and agree with the team members on availability for drafts and calendar for meetings
To ensure the scientific consistency between the different disciplines (CMC Departments, Industrial Affairs)
To coordinate and/or participate to the CMC Dossier Subgroup and CMC Coordination Team
Develop common understanding and ensure a working relationship with DARG to ensure successful and timely CMC filings and approvals
Ensure high quality CMC dossiers
Ensure timely availability of CMC dossiers obtained from documents provided by respective CMC departments, Industrial Affairs, and third party collaborations as applicable.
Ensure timely preparation and scientific review of all regulatory dossiers
In collaboration with DARG provide CMC risk assessment and options for management of that risk in major regulatory filings
Report and communicate CMC issues/resources related to CMC dossiers to the line management.
To attend Peer Review for MAA/NDA submission
To manage and validate CMC Change control with respect to global SOPs and directives/guidelines
To participate in the CMC Project CouncilsDOSSIER STRATEGY
Update CMC representatives in regulatory guidances & train in writing of regulatory documentsINTERACTION
Develop common understanding and ensure a working relationship with to ensure successful and timely CMC filings and approvals
Link to DSE and MPK Coordination for dossier & project related issues
REQUIREMENTS
Knowledge & Skills:
Knowledge of pharmaceutical development (Active Pharmaceutical Ingredient and/or Drug Product); Knowledge of international quality and regulatory guidelines; Excellent oral and written English communication skills; Ability to work independently and in cross-functional project teams; Ability to handle multiple project responsibilities and to adjust to changing priorities; Familiarity with pharmacopoeia; Attention to details; Working knowledge of GLPs, GMPs and ICH guidelines.Education/ Experience:
Ph.D. in Analytical Chemistry or a related field with 4-6 years experience or MS in Chemistry or a related field with 6-9 years of experience or BS in Chemistry or related field with minimum 10+ years experience in the Pharmaceutical industry.