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MISSION
As
CMC and Regulatory Associate you will be responsible for delivering the CMC strategy within internal and external projects through their lifecycle under the supervision and guidance of the Lead and/or Manager, and for delivering on CMC-related specific client requests to projects (e.g., contribution to the writing or reviewing of CMC part of regulatory dossiers, comparability studies, providing regulatory input to answer Health Authorities CMC questions). You will support the sharing of regulatory knowledge at Exothera.
RESPONSIBILITIES
Projects
- Takes the lead to deliver the CMC & Regulatory strategy for assigned projects from the project set-up under the guidance and review of the CMC Lead and/or Manager, including identification of relevant milestones and plans for their delivery. This includes but are not limited to:
- Ensure alignment of operational activities with Client’s CMC strategy,
- Develop written CMC plans/ strategies aligned with Client’s strategy and with regulatory expectations for the type of product and the clinical stage,
- Ensure the implementation of CMC recommendations received by the Client from Regulatory agencies and develop tracker tool if appropriate,
- Identify CMC risks and their mitigation approaches,
Ensures the delivery of CMC segments of process [and product if/when relevant] development in matrix environment. This includes but are not limited to:- Quality target product profile and identification of quality attributes and their criticality
- Building of control strategy (product control and process control) under the review of the CMC Lead and/or Manager, including identification of required in-process controls, release, characterization, and stability tests, with justification for the set-up of action limits or acceptance criteria; identification of process performance attributes and process parameters (CPP, KPP, non-KPP) with their target control ranges,
- Analysis and interpretation of product and process development data
- Contribute to the establishment of specifications for SM, DS, DP, diluent, placebo and excipients,
- Design (under the review of Lead and/or Manager) or review of stability studies
- Writing and/or reviewing development plans/ reports, risk assessments, position papers, SOPs and any other technical reports required to support regulatory filings
Contribute to the delivery of CMC part of regulatory files (for submission) as required to support the Client’s interactions with competent authorities, under the supervision of Lead and/or Manager
- Represent the voice of CMC & Regulatory team during project meetings (internal and external), report on CMC activities status in project team meeting and to Manager
- Identify the appropriate project contribution baseline (scope, timelines) and priorities
Knowledge sharing and regulatory surveillance
- Participate in regulatory surveillance around viral vectors-based products, and maintain the registry of regulatory references up-to-date, including its sharing in accordance with ‘Teach/Lead’ value of Exothera
- Write position papers or in-house guidance as per internal needs
QUALIFICATIONS & REQUIREMENTS
- PhD or MSc (or equivalent) in life sciences (or chemistry, or pharmacy) or related discipline
- At least 2 years of experience in CMC or regulatory or analytical fields in the biotherapeutics/biopharmaceutical/biotech or pharmaceutical industry
- Experience with viral vectors-based gene therapies or viral vaccines is an asset
- Knowledge of regulatory guidelines (EU, US, ICH, WHO), in particular in the field of viral vectors for Vaccines and Gene Therapies, is an asset
- Understanding of biologics development (process and product) principles, as well as understanding of general pharmaceutical development concepts (e.g., Quality by Design, analytical development, drug substance and product manufacturing).
- Full professional proficiency in English is a must (written and verbal)
- Scientific writing skills
- Ability to move forward multiple projects simultaneously with stringent timelines.
- Strong communication, presentation, and listening skills
- Problem-solving and negotiation skills
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