Regulatory Affairs Manager

We are partnered with a huge, international Life Sciences Consultancy who are searching for a freelance Regulatory Affairs Manager to support on a long-term project.

This project will run for a minimum of 1-2 years and is a full time and fully remote contract.

Responsibilities:

In this role, you will be responsible for all local regulatory affairs, lifecycle management (LCM) and maintenance activities for assigned products, including but not limited to the following:

· Variations (Administrative, Labelling, CMC, Safety, dossier harmonization)

· Preparation and submission of application dossier hard copy paper and/or electronic (CD, Web-based)

· Update Local PI (label and packaging components) (including labeling translation where local language is required

· Review advertising / promotional material against approved label

· Renewals

· Annual reports

· Issue Management (e.g., PQSC Quality, safety issues like out-of-stock situation management, DHCPL preparation coordination & submission in accordance to local regulations & company SoPs, representing RA in related internal committees)

· Regulatory Intelligence for the portfolio in scope

· Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities

· CTA (Clinical Trial Applications for Established Products) (where applicable)

· Parallel Import check of goods (where applicable)

· Global regulatory team participation for selected established portfolio products

· Primary contact for Local Health Authority on delegated products