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Regulatory Affairs Manager

2 months ago

St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Job Summary

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 Monitoring: Identify and remediate compliance gaps, ensuring that all regulatory requirements are met.
  • Documentation and Submission: Gather, consolidate, and analyze documentation, and submit regulatory filings to relevant authorities.
  • Regulatory Support: Provide product and regulatory expertise to support the contract manufacture of current products and the introduction of new products.
  • Process Improvement: Contribute to the creation, maintenance, and continuous improvement of Regulatory processes, policies, and systems.
  • Team Leadership: Supervise assigned team members, provide training, and participate in resource planning and recruitment procedures.
Requirements
  • Regulatory Knowledge: In-depth understanding of GMP, Quality, and Regulatory requirements.
  • Communication Skills: Excellent communication and interpersonal skills, with the ability to work with stakeholders at all levels.
  • Technical Skills: Proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
  • Regulatory Awareness: Maintaining awareness of changing regulatory requirements.