Regulatory Labelling Lead

Wipro Technologies; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading multinational company in England is seeking a professional to manage labeling documents, ensuring compliance with regulatory requirements. The ideal candidate will have 4-6 years of experience in the pharma or medical device sector, hands-on registration experience, and strong communication skills. This role offers opportunities for professional growth in a flexible remote work environment with extensive benefits.

Benefits

Fast-growing multinational environment

Career growth opportunities

Flexible fully remote work

Access to diverse benefits

Personal and professional development programs

Comprehensive salary package

Reward and recognition schemes

Qualifications

• 4-6 years of experience in the pharma or medical device industry.
• Significant hands-on registration experience in regulatory affairs.
• Ability to interpret and apply global and local regulatory guidance.

Responsibilities

• Accountable for creation and updates to labeling documents.
• Guiding the labeling team in maintaining Core Data sheets.
• Ensures compliance with regulatory requirements.

Skills

Experience in pharma or medical device industry

Written and verbal communication skills

Project management skills

Job description

Key Responsibilities

• Has overall accountability for the initial creation and relevant updates to labeling documents
• Guiding the labeling team to develop and maintain Core Data sheets, USPI, SmPC and associated patient labeling documents along with regulatory authority‑driven documents such as Core Safety Profile
• Stays updated with labeling guidelines and regulations pertaining to the development and maintenance of US and EU labeling
• Is knowledgeable on key labeling requirements worldwide to ensure global implementation of CDS updates; reviews downstream impact on Local Product Documents (LPDs) and ensures that impact is considered during labeling team discussions
• Provides project management to the labeling team throughout the entire process, from decision making to updates in CDS / USPI / SPC
• Acts as a reviewer and signatory during labeling review, ensuring content complies with regulatory requirements
• Facilitates cross‑functional team awareness and understanding of regulatory issues as appropriate
• Contributes to local or global system and process improvements

Requirements

• 4‑6 years of experience in the pharma or medical device industry
• Significant hands‑on registration experience associated with development, maintenance, and commercialization activities within regulatory affairs
• Understanding of regulatory implications of product strategy with regards to the product label & assessment
• Ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation
• Excellent written and verbal communication skills
• Proven strength in logical, analytical and writing ability
• Demonstrated project management skills and attention to detail

Preferred Skills

• Proven understanding of the dynamics and purpose of CDS; experience reviewing CDS and its implications
• Prior experience with biologicals

Benefits

• Opportunity to work in a fast‑growing company and in a multinational environment for some of the biggest brands in the world
• Potential for career growth within the organization and the opportunity to build a successful career path
• Flexible and fully remote work environment, allowing you to work from the comfort of your home in any city in Europe
• Access to a diverse range of benefits
• Personal and professional development through a variety of training programs covering both hard and soft skills
• Comprehensive salary package with various components
• Complex reward and recognition schemes (both non‑monetary and monetary options)