Regulatory Compliance Manager
1 week ago
We are seeking a Regulatory Compliance Manager to join our team at Norgine. In this role, you will be responsible for ensuring compliance with MAH oversight procedures and building relationships with internal stakeholders and service providers.
The ideal candidate will have experience supporting projects within the pharmaceutical industry and have great prioritisation and excellent organisational skills. They will also have excellent written and verbal communication skills and be able to communicate with all levels. The estimated salary for this role is £55,000 - £75,000 per year.
Main Responsibilities:
- Supports preparation and review of governance data and metrics and participates in Operational Governance Committees for the outsourced activities
- Onboards and offboards vendor's resources and ensures all required documentation is available
- Supports Service Provider training activities including reconciliation of training plans and training compliance
- Tracks and manages requests from business and business partners and escalates issues that may impact compliance
- Coordinates review and approval of legal documents i.e. Contracts and Power of Attorneys (PoAs) and ensures comments are addressed and signatures collected in a timely manner
- Supports financial activities including coordination of review of financial trackers from Service Providers, liaising with SME's and service providers to ensure financial discrepancies/queries from either party are resolved in a timely manner
- Maintains databases: Contract database, PoA database, Vendor resource database, Request database
- Delivers data to support inspection/audit requests and participates in health authority inspections and partner audits
- Supports major change management initiatives including product acquisitions/integrations and product divestments
- Supports in development of manuals that describe the split of responsibilities between Norgine and the services providers and co-author internal Norgine procedures
- Identifies and implements improvements that enhance performance and drive effectiveness
- Deputises for the Operations Governance Manager
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