Regulatory Affairs Officer

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Job description

The Client

A leading, global pharmaceutical company, with their UK headquarters based just outside Croydon, is looking to add to their ever growing Regulatory Affairs team.

This team consists of experienced RA professionals that support the businesses portfolio across the UK and Europe.

The Role

Working as an RA Officer alongside the rest of the RA team, your responsibilities will include:

• Ensure the compliance of the company's products with regulatory requirements
• Support the regulatory department with regulatory submissions
• Assist and coordinate site transfer projects
• Prepare submissions of authorization changes and renewals
• Liaise with regulatory bodies to facilitate the approval of submissions
• Maintain up-to-date records and documentation in relation to Marketing Authorizations
• Assist in the preparation of procedures for relevant regulatory activities
• Comply with company policies and guidelines
• Maintain regulatory files/database and chronologies
• Perform product information compliance activities
• Check, approve and release labeling/ packaging documents
• Work closely with in-house, 3rd party designers and contract sites for packaging artwork development and updates
• Work with outsourced Pharmacovigilance team for new MA applications, submissions related to Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs) and renewals
• Support and maintain labeling systems, process and related activities
• Identify any compliance issues or gaps and support Line Manager in evaluating business impact and corrective actions
• Gather all required documentation for the administrative sections of CTD dossier
• Work collaboratively across organization and contract sites
• Perform other appropriate duties, where necessary

The Requirements

• Experience with communicating with regulatory bodies at an administrative and strategic level
• Good understanding of European / UK regulatory guidelines, regulations and procedures
• Understanding of the timescales of the approval processes within regulatory bodies
• Understanding of company Regulatory Affairs SOP's
• Understanding of pharmacovigilance practices and procedures

The Benefits

25K - 35K salary

Hybrid working (3 days at home, 2 days on site)

Additional Benefits

Response

Click Apply now to learn more about this position, and to speak with one of our consultants today.

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