Regulatory Compliance Officer
6 days ago
Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and managing post-approval changes for Marketing Authorisations.
Key Responsibilities- Post-Approval Change Management: Manage post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause.
- Regulatory Filing Strategy: Develop and implement filing strategies and manage submission timelines to ensure timely and compliant regulatory submissions.
- Compliance Gap Identification and Remediation: Identify and remediate compliance gaps, ensuring that all regulatory requirements are met.
- Documentation and Submission: Gather, consolidate, and analyze documentation, and submit regulatory filings in a timely and accurate manner.
- Regulatory Support: Provide regulatory expertise and support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management, and other stakeholders as needed.
- Process Improvement: Contribute to the creation, maintenance, and continuous improvement of Regulatory processes, policies, and systems.
- Regulatory Knowledge Management: Maintain up-to-date knowledge of Regulatory and Quality Management requirements to support the contract manufacture of current products and the introduction of new products.
- Team Leadership: Supervise assigned team members, provide training, and participate in resource planning and recruitment procedures.
- Compliance and Quality: Ensure compliance with company policies, procedures, and training expectations.
- Regulatory Knowledge: In-depth understanding of GMP, Quality, and Regulatory requirements.
- Communication and Stakeholder Management: Excellent communication and interpersonal skills, with the ability to work with a range of stakeholders, at all levels, both internally and externally.
- Technical Skills: Proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
- Regulatory Awareness: Maintaining awareness of changing regulatory requirements.
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St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full timeJob SummaryAchieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and managing post-approval changes for Marketing Authorisations.Key ResponsibilitiesPost-Approval Change Management: Manage post-approval...
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