Job Description

job details

The main purpose of the role:
To manage an assigned portfolio of products (mostly Innovative assets) in the UK & European region and ensure day-to-day life cycle maintenance of Marketing Authorizations to keep the MAs compliant and enable supply continuity working cross-functionally. Key responsibilities (In Points): ...

• Provide guidance and advice about UK and EU post-approval requirements and influence product strategy, any ongoing clinical program and life cycle management processes.
• Develop and implement regulatory strategies for UK and Europe for post-approval activities associated with Renewal, Variations, PSUR submissions, safety updates, Paediatric investigation plan (PIP) management and other labelling updates associated with the New Chemical Entities/Orphan designated products and any other innovative assets added to the portfolio.
• Lead and manage the preparation of and/or provide input into regulatory documents, including briefing materials for health authority meetings, post-approval variations, health

authority queries, other international regulatory submissions and country-specific labelling.
o Authoring of Module 1
o Review of CTD modules with emphasis on Clinical modules
o Liaise cross-functionally internally and sometimes with external partners to manage the collaborative review

• Manage European regulatory procedures (mostly Centralized procedures) interact with European and UK Health authorities (Rapporteur, Project coordinators), respond to requests by regulatory authorities, organize and manage participation in meetings and contribute to the development of strategies to address such requests.
• Oversight of distributors and in-country consultants\' negotiations with regulatory authorities regarding the company\'s applications.
• Author and manage regulatory procedures to expand the product in other markets having similar regulatory requirements like the EU show more

Randstad