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Regulatory Affairs Specialist

2 months ago

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 post-approval changes of Marketing Authorisations and product life cycle management. This includes maintaining MIA and WDA, filing strategy, and managing submission timelines. You will also be responsible for identifying and remediating compliance gaps, gathering and consolidating documentation, and submitting regulatory filings.

Key responsibilities include:

* Maintaining up-to-date knowledge of regulatory and quality management requirements
* Providing product and regulatory expertise to support post-marketing changes and new product introduction
* Building good working relationships with CMOs and cross-functional teams
* Supervising assigned team members and participating in resource planning and recruitment
* Ensuring compliance with company policies, procedures, and training expectations

Requirements:

* Strong understanding of GMP, quality, and regulatory requirements
* Excellent communication and stakeholder management skills
* Proficiency in publishing and compilation of eCTD submissions
* Ability to maintain awareness of changing regulatory requirements

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

Please note that this job description is a summary of the main responsibilities and requirements for the role. It is not an exhaustive list of tasks and duties.

Achieva Group Limited is an equal opportunities employer and welcomes applications from all qualified candidates.

We are committed to diversity and inclusion and aim to create a workplace that is free from discrimination and harassment.

Thank you for considering this opportunity. We look forward to hearing from you.

Best regards,

[Your Name]"}