Manager, Regulatory Global Labeling

Overview

Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.

We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research And Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

SUMMARY This position will be responsible for leading the development, review, and management of US, EU, and International labeling for a product in development and commercial products. The incumbent will be responsible for assessing and managing labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages. The Reg Global Labeling Manager (GLM) will ensure the appropriate labeling strategies are communicated to project teams;

compliant with core labeling and local regulations; ensure the labeling is accurate and of the highest quality; and support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status.

• The GLM leads the assigned product labeling teams (PLTs) and supports labeling positions.
• Close collaboration with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams to ensure the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with Bio Marin’s labeling processes and standards.
• Preparation of labeling content based on source documents such as CSRs, regulatory requirements and other reference documents.
• Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content.
• Facilitate the review and approval process within the product labeling teams, including outlining the label history and documentation of team decisions. Provide and maintain background documents outlining the purpose and justifications for labeling changes. This includes local labeling content and global labeling content (CCDS).
• Manage approved labels in a label management database/corporate system to ensure accurate and up to date labeling is available and accessible at all times.
• Maintain knowledge of current rules and regulations governing global labeling activities.
• Receive and collate labeling text from labeling team members and manage labeling content and revision control. Assess text for compliance with labeling requirements and provide team recommendations on appropriate text for labeling content.
• Reviewing and approving artwork and change control related to labeling activities.
• Supporting launch and/or release of revised labeling into production.

• Prepare labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS, and assist with the preparation of high quality documents to support the creation of the CCDS and/or changes to the local labeling for assigned projects or marketed products.
• Represent…