CH - Associate Director, EU Regulatory CMC assessment
CKQLS is are recruiting for a CH - Associate Director, EU Regulatory CMC assessment , to join an important project with a Global Pharmaceutical Company at their site based in Zurich on a contract basis for 12 months with option of an extension.Job description :
Under supervision from a senior team member and / or Line Manager defines, develops and sometimes leads regional CMC strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
Works with the RA CMC leads and contributing functions to achieve a high quality change description and supporting documentation
Assesses regulatory impact in EU region of proposed CMC changes, including determination of type of procedure and possibility of grouping, and effectively communicates objective assessments of the likelihood of success of these regulatory strategies
Records the regulatory impact assessment, the assessment or regulatory procedure submission, approval dates in Quality Change Control System and other systems, as applicable.
Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient CMC regulatory submissions in the region , while maintaining full compliance with applicable regulatory requirements
Identifies the required documentation and any content, quality and / or timelines issues for EU CMC submissions and negotiate the delivery of approved technical source documents in accordance withproject timelines.
Leads in close collaboration with CMC manager the preparation of submission packages for relevant CMC variations
Provides regional regulatory expertise for assigned development and / or life cycle management projects within the therapeutic area of responsibility
Responsible for assessing and confirming the High Level impact assessment performed by Global CMC lead
Responsible for updating the previously performed impact assessment, if applicable, communicating thisupdate to the Global RA CMC Lead and EU RL to ensure the applicable change control record is updated and applicable necessary further actions taken.
Responsible for assessing the CMC change impact to SmPC / PIL / labelling. Strong planning, negotiation, organizational and social skills.
Works closely with the EU RL and the Global RA CMC lead to ensure the agreed submission strategy is executed
BSc. Advanced scientific related degree preferred;Advanced degree preferred
Considerable experience within the pharmaceutical industry and including direct experience in CMC regulatory affairs in development and post-marketing phases for medicinal products
Experience in Medical Device regulation as an advantage
Experience in CMC regulatory affairs for biological / biotechnological products as an advantage
Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy
Strong expertise in the EU region : CMC lifecycle maintenance, Variation Regulation / Guideline; preferred experience in managing multiple filings;
or managing multiple programs in closely related development area Generally strong in all basicskills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability