Lead, Project Management - Remote

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. 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.

Key Responsibilities:

• 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.
• Stay updated with labeling guidelines and regulations pertaining to the development/maintenance of US and EU labeling.
• Ensure knowledge of key labeling requirements worldwide to implement CDS updates globally.
• Review the downstream impact of CDS updates on Local Product Documents (LPDs) and ensure this is considered during Labeling Team discussions.
• Provide project management to the Labeling team throughout the entire process, from decision making to updates in CDS/USPI/SPC.
• Act as a reviewer and signatory during the review of labeling ensuring that content complies with regulatory requirements.
• Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
• Contribute to local or global system and process improvements.

Qualifications:

• 4-6 years of experience in the Pharma or Medical Devices industry.
• Significant hands-on registration experience associated with development, maintenance, and commercialization activities within Regulatory affairs.
• Understand 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.
• Proven strength in logical, analytical and writing ability.
• Demonstrate project management skills and attention to detail.

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. Personal and professional development through a variety of training programs covering both hard and soft skills. Complex reward and recognition schemes (both non-monetary and monetary options). Referral schemes.