Cache of job #13942184

Job Title

Senior Cmc Specialist

Employer

Brightwater

Location

Cork

Description

An expanding Biologics site in Cork requires an experienced CMC specialist to bolster their existing Regulatory Affairs team and support CMC activities for their CMO sites. Working in a collaborative and supportive structure with progression opportunities this could be the next great step in your career! About the Job: Support the establishment and operation of practices and processes to ensure that CMOs operate in accordance with the approved authorisations. Ensure that regulatory-impacting changes arising from CMOs are accurately assessed for regulatory impact. Ensure that submission and approval statuses for filings impacting the CMO are communicated in a timely manner. Ensure that implementation requirements and any BOH commitments are clearly communicated. Act as CMC point of contact in advising and addressing ad-hoc regulatory CMC and conformance issues that arise at CMOs. Provide CMC subject matter expertise where appropriate to deviations and notifiable events and BOH inspections at CMOs. About You: A scientist, technical or regulatory specialist, with a strong understanding of CMC matters. Bachelor’s degree or higher in science. Direct experience of CMC regulatory affairs, gained in a manufacturing environment or regulatory agency. Experience of working with external partners and companies is an advantage. Effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks. Proven ability to communicate effectively in both a written and verbal format. Ability to influence and work both independently and collaboratively in a team structure in geographically diverse team structure. Proven ability to work well under pressure. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

Date Added

2015 days ago

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