What to Expect
* Line management, training of Regulatory Specialist
* Training of the direct reports in EMEA / FDA requirements
* Establish and manage regulatory submission timelines for both new and existing products across key global markets
* Engage with regulatory authorities and distribution partners to support product registrations
* Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
* Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
* Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
* Support and participate in inspections and audits conducted by global regulatory authorities.
Requirements
* Min 8 years in regulatory affairs
* Min 4 years as Regulatory Affairs Manager
* Experience with EMEA / FDA regulatory requirements
* Ideally line management of a team
* Excellent written and verbal in English
* Availability to work 4 days in the office
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk
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