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. Be knowledgeable on key labeling requirements worldwide to ensure CDS updates are implemented globally.
5. Review the downstream impact of CDS updates on Local Product Documents (LPDs) and ensure considerations are incorporated during Labeling Team discussions.
6. Provide project management to the Labeling team throughout the entire process, from decision-making to updates in CDS/USPI/SPC.
7. Act as a reviewer and signatory during labeling review to ensure content compliance with regulatory requirements.
8. Facilitate cross-functional and team awareness and understanding 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 concerning the product label & assessment.
4. Ability to interpret and apply global and local regulatory guidance around labeling and supportive 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 with review and implications of CDS.
2. Prior experience with biologicals.

Benefits:

1. Opportunity to work in a fast-growing company and in a multinational environment for some of the biggest brands in the world.
2. Potential for career growth within the organization and building a successful career path.
3. Flexible and fully remote work environment, allowing you to work from anywhere in Europe.
4. Access to a diverse range of benefits.
5. Personal and professional development through various training programs covering hard and soft skills.
6. Comprehensive salary package with various components.
7. Complex reward and recognition schemes (both monetary and non-monetary).
8. Referral schemes.