GSK
pharmaceutical
RegulatoryConformanceOfficer
“Regulatory Conformance Officer at GSK. Skills: regulatory conformance, regulatory compliance, product licensing. maintaining the approval status of product licenses for both new and established products. upholding the manufacturer's licenses for our Barnard Castle facility”
What You'll Achieve.
ensuring our products meet all licensing requirements and company standards; delivering excellence in regulatory conformance and compliance; delivery of critical regulatory projects across the product lifecycle; ensuring site operations remain aligned with changing regulatory requirements; ensuring that processes, specifications, and controls remain compliant and robust; ensuring alignment with regulatory requirements; ensure compliance
Industry & Context.
12-month Fixed Term Contract (FTC) / Secondment, fully site based
What They're Looking For.
Must Have
HND or ‘A’ levels in Scientific disciplines or equivalent experience, Background in analytical, laboratory, pharmaceutical industry, or regulatory roles, analytical approach with excellent attention to detail, Understanding of the regulated industry and its requirements, including Quality and GxP, Ability to interpret and apply registered details to ensure compliance in manufacturing and release processes
Nice to Have
Broad-based technical knowledge of manufacturing, quality, and regulatory activities/requirements, with knowledge of change control processes, registration, and regulatory procedures being desirable, Degree in a scientific or related discipline (e. g. , Microbiology, Pharmacy, Chemistry, or another related science)
What You'll Do.
maintaining the approval status of product licenses for both new and established products
upholding the manufacturer's licenses for our Barnard Castle facility
offering regulatory information and support for site transfers and variations to existing products within agreed customer deadlines
maintaining compliance with global market authorisations
supporting regulatory submissions
ensuring site operations remain aligned with changing regulatory requirements
delivery of regulatory strategies
change implementation
ensuring that processes
and controls remain compliant and robust
support the commercialization of new products from R&D through development
and commercial submissions
coordinating submission authoring
and approval for the site
providing accurate and compliant information to support regulatory filings
Represent Regulatory Conformance in project teams for new business
ensuring alignment with regulatory requirements
Coordinate and prepare responses to questions from external regulatory authorities during technical reviews of submissions
managing the delivery of data/information to fulfil post-approval commitments
Review site requests for change
assess regulatory impact
provide accurate advice to change owners/initiators
support the Regulatory Implementation Strategy
communicating approval status to the site
Assess regulatory changes for site impact
escalate issues to ensure compliance
review Quality and Regulatory Intelligence
communicate impacts to the site
report regulatory intelligence to Central Regulatory
review Pharmacopoeia changes for specification impact
How You'll Work.
Team & Collaboration
Collaborate with multiple functions across the site and the global network; establishing partnerships with Operational Quality, New Product Introduction, Analytical Laboratories, Validation, Logistics, R&D, Global Regulatory Affairs, and Local Operating Companies; Represent Regulatory Conformance in project teams for new business, change projects, transfers, and network strategy; Working closely with manufacturing and aseptic operations
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