Regulatory Labelling Lead

Wipro; Maidstone; Remote; GBP 50,000 - 75,000; Full time

Job summary

Wipro is seeking a Regulatory Labelling Lead for a project with a prominent biopharmaceutical company. This fully remote position involves guiding labeling documentation for innovative treatments in the rare disease sector. Ideal candidates will have solid experience in regulatory affairs, with opportunities for career growth in a dynamic environment.

Benefits

Flexible, fully remote work environment

Access to diverse benefits and professional development programs

Comprehensive salary package

Reward and recognition schemes

Qualifications

• 4-6 years of experience in Pharma or Medical Devices industry.
• Strong regulatory affairs experience in labeling and documentation.
• Excellent written and verbal communication skills.

Responsibilities

• Accountable for the creation and updates to labeling documents.
• Guide team to maintain Core Data sheets and USPI.
• Act as reviewer during labeling review to ensure compliance.

Skills

Analytical skills

Project management

Communication

Job description

The Regulatory Labelling Lead role is part of a project with a leading biopharmaceutical company focused on developing innovative treatments for rare and ultra-rare genetic diseases. If you are passionate about working with a renowned organization committed to advancing research and supporting patients and families affected by these conditions, we encourage you to apply. This position offers the opportunity to collaborate with healthcare professionals, researchers, and advocacy groups, making a meaningful impact in the rare disease community. The role is fully remote and can be performed from anywhere in Europe. Join us and be part of our inspiring journey of growth!

Responsibilities:

1. Have overall accountability for the initial creation and relevant updates to labeling documents.
2. Guide 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.
3. Stay updated with labeling guidelines and regulations pertaining to the development/maintenance of US and EU labeling.
4. Ensure knowledge of key labeling requirements worldwide to facilitate global CDS updates.
5. Review the downstream impact of CDS updates on Local Product Documents (LPDs) and consider this during Labeling Team discussions.
6. Provide project management to the Labeling team throughout the process, from decision-making to updates in CDS/USPI/SPC.
7. Act as a reviewer and signatory during labeling review to ensure regulatory compliance.
8. Facilitate cross-functional and team awareness of regulatory issues as appropriate.
9. Contribute to local or global system and process improvements.

Requirements:

1. 4-6 years of experience in the Pharma or Medical Devices industry.
2. Significant hands-on registration experience related to development, maintenance, and commercialization activities within Regulatory Affairs.
3. Understanding of regulatory implications of product strategy regarding labeling and assessment.
4. Ability to interpret and apply global and local regulatory guidance around labeling and documentation.
5. Excellent written and verbal communication skills.
6. Proven strength in logical, analytical, and writing abilities.
7. Demonstrated project management skills and attention to detail.

Good to have skills:

1. Understanding of the dynamics and purpose of CDS; experience reviewing and understanding CDS implications.
2. Prior experience with biologicals.

Benefits:

1. Opportunity to work in a fast-growing company within a multinational environment for some of the biggest brands.
2. Potential for career growth and building a successful career path.
3. Flexible, fully remote work environment across Europe.
4. Access to diverse benefits and personal/professional development programs.
5. Comprehensive salary package with various components.
6. Reward and recognition schemes, referral schemes.