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Regulatory Affairs Specialist

2 months ago

St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
{"h1": "Regulatory Affairs Manager", "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.

In addition, you will coordinate and prepare written responses to requests for information from regulatory authorities, monitor the status of regulatory applications, and review and assess the regulatory impact of change control/requests. You will also provide product and regulatory expertise and clarification on RA requirements for post-marketing changes and new product introduction.

The ideal candidate will have a strong understanding of GMP, Quality and Regulatory requirements, and be able to communicate effectively with a range of stakeholders. You will also have proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.

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

**Key Responsibilities:**

* Manage post-approval changes of Marketing Authorisations and product life cycle management
* Maintain MIA and WDA, filing strategy, and manage submission timelines
* Identify and remediate compliance gaps
* Gather and consolidate documentation and submit 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
* Provide product and regulatory expertise and clarification on RA requirements

**Requirements:**

* Strong understanding of GMP, Quality and Regulatory requirements
* Ability to communicate effectively with a range of stakeholders
* Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools

**What We Offer:**

* Competitive salary and benefits package
* Opportunity to work with a dynamic and growing company
* Collaborative and supportive work environment

If you are interested in this exciting opportunity, please submit your application, including your resume and a cover letter, to [insert contact information].

We thank all applicants for their interest; however, only those selected for an interview will be contacted.

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

**Note:**

This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job.

Achieva Group Limited reserves the right to modify or change job duties, responsibilities, or qualifications as needed.