Regulatory Affairs Specialist
3 days ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Achieva Group Limited. The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.
Key Responsibilities- Manage post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause.
- Maintain MIA and WDA, including API import registration.
- Develop and implement filing strategies and manage submission timelines.
- Identify and remediate compliance gaps.
- Gather, consolidate, and analyse documentation for regulatory filings.
- Coordinate and prepare written responses to requests for information from regulatory authorities.
- Monitor the status of regulatory applications.
- Review and assess the regulatory impact of change control/requests for the manufacturing, testing, and release of drug substance and drug product.
- Provide product and regulatory expertise and clarification on RA requirements for post-marketing changes and new product introduction.
- Support supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary.
- Contribute to the creation, maintenance, and continuous improvement of Regulatory processes, policies, and systems.
- Maintain up-to-date knowledge of Regulatory and Quality Management requirements.
- Build good working relationships with CMOs and cross-functional teams.
- Supervise assigned team members with respect to management and training.
- Participate in resource planning and recruitment procedures.
- Ensure compliance with company policies, procedures, and training expectations.
- Understanding of GMP, Quality, and Regulatory requirements.
- Excellent communication and stakeholder management skills.
- Proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
- Maintaining awareness of changing regulatory requirements.
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St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time{"h2": "Regulatory Affairs Manager Role", "p": "Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a passion for ensuring compliance.As a Regulatory Affairs Manager, you will be responsible for managing...
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St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time{"h2": "Regulatory Affairs Manager Role", "p": "Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a passion for ensuring compliance.As a Regulatory Affairs Manager, you will be responsible for managing...
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