Associate Director, Global Regulatory Labeling

Job Description

As the Associate Director, Global Regulatory Labeling you will be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level. In this role, you may be responsible for overseeing the strategy for other products within your Therapeutic Area and may have direct reports.

· Lead timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile and Target Product Profile.

· Organize and lead cross functional product Global Labeling Team to reach consensus on core labelling matters, accurately capture and communicate decisions, and obtain endorsement by senior management.

· Propose the strategy to be followed in core labelling documents, ensuring alignment with global regulatory strategies.

· May oversee core labeling documents for all products within a Therapeutic Area and may have direct reports.

· Oversee timely implementation of CDS updates in regional labels and monitor compliance to labeling processes.

· Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labeling and collaborate with Regulatory Leads to identify and track Country Labeling Differences.

· Oversee preparation of supporting documents for core labeling changes, in collaboration with Medical Writing, ensuring alignment to the core labeling strategy and global regulatory strategy.

· Oversee and/or maintain labeling compliance for products within assigned Therapeutic Area ensuring version control and tracking of CDS implementation in relevant company systems.

· Create, maintain and update regulatory labeling procedures and SOPs and support relevant audits and inspections.

· Maintain knowledge of current rules and regulations governing global labelling activities.

· Provide training to internal stakeholders, new joiners on labeling requirements and standards.

You have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will have an excellent eye for detail and a demonstrated understanding of the importance of labeling governance and compliance.

#LI-TD1

Qualifications

· Minimum of 6 to 8 years’ experience working in a drug regulatory affairs and/or drug labeling

· Understanding of Pharmacology/medicine/pharmacovigilance/drug development

· Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts

· Knowledge of global/regional regulatory guidelines and requirements

· Bachelor's degree in a scientific or medically related discipline preferred

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.