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:
* Has overall accountability for the initial creation and relevant updates to labeling documents
* Guiding the labeling team to develop and maintain Core Date sheets, USPI, SmPC and associated Patient Labeling documents along with regulatory authority driven documents such as Core Safety Profile
* The lead needs to be updated with labeling guidelines and regulations pertaining to the development/maintenance of US and EU labeling
* Should be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS updates may be implemented globally. The lead will review the downstream impact of CDS updates on Local Product Documents (LPDs) and ensure that downstream impact on LPDs is considered during Labeling Team discussions
* Provides project management to the Labeling team throughout the entire process, from the decision making to updates in CDS/USPI/SPC
* Act as a reviewer and signatory during 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
Requirements:
* 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
* Excellent written and verbal communication skills
* Proven strength in logical, analytical and writing ability
* Demonstrate project management skills and attention to detail
Good to have skills:
* Proven understanding of the dynamics and purpose of CDS; experiences of review and implications of CDS
* 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).
* Referral schemes.