Regulatory Affairs Consultant

1 month ago

Uxbridge, United Kingdom Parexel Full time

When our values align, there's no limit to what we can achieve.
 

The purpose of the Global Labelling group is to drive the core labelling strategy and ensure that labelling documents are of high quality and compliant for the safe and effective use of our products for patients and healthcare providers globally. As the Global Labelling Lead , you would be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level.

This is a client dedicated project. The role can be home or office based in various European locations.

Role Overview

Create and Update Core Labelling Documents

Lead the timely creation/management of regulatory compliant, competitive, and up-to-date core labelling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet, and Target Label Profile.

Lead cross-functional product Global Labelling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management.

Propose the strategy to be followed in core labelling documents, ensuring alignment with global regulatory strategies.

Oversee distribution and tracking of CDS updates, ensuring compliance is maintained within the EDMS and the Regulatory Tracking System.

Oversee Regional Implementation

Oversee timely implementation of CDS updates in regional labels and monitor compliance to labelling processes.

Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labelling and collaborate with Regulatory Leads to identify and track Country Labelling Differences.

Core Labelling Supporting Documentation

Oversee preparation of supporting documents for core labelling changes, in collaboration with Medical Writing, ensuring alignment to the core labelling strategy and global regulatory strategy.

Maintain Labelling Compliance

Maintain labelling compliance for assigned products, ensuring version control and tracking of CDS implementation in relevant company systems.

Create, maintain and update regulatory labelling procedures and SOPs and support relevant audits and inspections.

Maintain knowledge of current rules and regulations governing global labelling activities.

Provide training to internal stakeholders, new joiners on labelling process requirements, and content standards.

Basic to Advanced Level of Skill in Key Labeling Capabilities Including:

Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, and influence the clinical development plan.

Develop and implement a strategy for global labeling content.

Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team.

Partner with key stakeholders to ensure product labeling is the most current, accurate, relevant, and competitive to inform prescribers and patients.

Provide tactical guidance to product labeling review teams regarding labeling content development.

Recognize potential regulatory issues, solutions, and opportunities.

Show the value labeling brings to the business by owning labeling content.

Skills and Experience required for the role:

Bachelor's degree in a scientific or medically related discipline preferred.

3 to 7 years pharmaceutical/biotechnology industry regulatory experience, including regulatory labelling.

Proven experience with document management and regulatory tracking systems.

Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts.

Demonstrate strong organizational skills, including the ability to prioritize personal workload.

Ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.

Well organized, detail-oriented, highly effective written and oral communication skills.

Fluent in English, written and spoken

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