Manager, Regulatory Global Labeling

BioMarin Pharmaceutical•San Rafael, CA

About The Position

BioMarin 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.

Requirements

4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD), 2+ years in Regulatory Affairs.
Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
US and/or EU Labeling experience minimally required and core labeling experience highly desired
Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
Experience with E2E global labeling processes and management of Company Core Data Sheets
Experience in review process, standards, and industry best practice pertaining to labeling
Strong scientific background and/or experience
Working knowledge of medical terminology and drug safety
Proven project management, leading teams from multiple functional areas
Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labeling
Excellent verbal and written communication skills; strong technical writing and presentation skills
Must be able to work as a team member and independently
Strong attention to details required and high-quality work
Fluency in English as business language, additional languages advantageous
Ability to travel (up to 15%) for industry conferences or other business meetings
Flexibility to work occasional nights and weekends as determined by critical Regulatory deadlines
Minimum requirements BS or MS with requisite experience and demonstrated capability.
Science or medical background desirable.

Nice To Haves

Experienced processing and assessing translations of labeling a plus.
International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable.

Responsibilities

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 BioMarin’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 REG GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) and work in close collaboration with the Global Regulatory Lead (GRL) and relevant line function expert(s) on creation/maintenance of core labeling documents.
Participate on Product Core Teams and present strategic global labeling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products.
Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices.
Document control and distribution of product labels (prescribing information, carton and container labeling) including drafting initial documents, annotations, coordinate the generation of, and review SPL files, prepare final labeling.
Project management role of logistical activities and delivering labeling documents within agreed timeframes.
Create and maintain regulatory compliant, competitive and up to date Company Core Data Sheets for assigned key development projects and marketed products.
Ensure adequate reflection of key regional input (e.g. EU, US, International Markets) when developing or revising the CCDS.
Prepare and manage International labeling including tracking differences in local labels to the CCDS, ensuring local requirements are met, and translations are properly executed.
Manage translations and address discrepancies with local partners and linguistic experts, ensuring alignment with source content.
Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes in local product information, international consistency with the company’s position defined in the CCDS and as established by the PLT, and compliance with local labeling regulations.
Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.
Assess country-specific deviations from the CCDS for assigned key development projects and marketed products.
Provide RA input to Periodic Safety Update Report (PSUR) and Annual Reports for assigned products.
Support the development of artwork and approve new or revised labeling to be implemented into production.
Approve all change requests for revised labeling for assigned projects/products.
Provide Supply Chain and QA guidance on labeling implementation requirements.
Support first launch into new markets.
Contribute to global labeling management and continuous improvement initiatives.
Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes.