Global Labeling Operations Manager, Regulatory Affairs

Location:  San Rafael, California Category: Regulatory

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Position: Reg Global Labeling Operations Manager, Regulatory Affairs

SUMMARY

This position will be responsible for supporting the development, review, and management of US, EU, and International labeling for commercial products.  Responsible for QC assessment and managing labeling changes for lifecycle products. The Reg Global Labeling Operations Manager will ensure the appropriate labeling processes and tools are available to the labelling group; review of processes and systems to ensure fit for purpose; ensure systems are maintained, accurate and of the highest quality. Support on implementation of approved labels may include initiating artwork requests in the artwork management system, annotating labels, review of change management records, document control, QC’ing documents, translations and verification of translations, and tracking project milestones and status.  

RESPONSIBILITIES

This position will be responsible for:

Labeling Processes Development, Artwork Management and Labeling Requirements

  • Initiate artwork requests and requirements for implementation of new or revised labeling components
  • Manage implementation requirements worldwide
  • Maintain repository for regulatory intelligence for labeling requirements worldwide
  • Provide input to internal tracking systems/databases to control workflow and ensure labeling projects/submissions and implementation deadlines are met
  • Assist with regulatory research supporting labeling activities
  • Communicate with labeling managers to ensure any new regulatory requirements are incorporated into the labeling documents

Support LIP activities

  • Provide consistency to GLL and Operations staff on LIP best practices
  • Work with Packaging Operations and Supply Chain to facilitate implementation of labeling for printed packaging components.
  • Monitoring launch and/or release of revised labeling into production.
  • Ensuring highest quality for preparation of labeling content, components, and supporting documentation.
  • Launch/Implementation: Review final artworks 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.

Tracking and compliance oversight

  • Tracking labeling changes are entered on time and high quality in GDT.
  • Developing and maintaining GDT User Manual
  • Acting as a Superuser for GDT and contact with vendor on system support
  • Tracking and metrics for all on-going labeling projects
  • Provide metrics reporting on status of submissions and implementation, including but not limited to reports for ELC quarterly meeting, and monthly labelling meetings.
  • Support Product Labeling Leads in the maintenance of labeling regulatory / quality systems, and updating and managing electronic labeling files (e.g. LIP, AMS, TrackWise).
  • Managing and coordinating the development of labeling processes and tools (such as web-based eTools (e,g, SharePoint collaboration site), manuals, checklists, etc)

Review and prepare labeling documents

  • Provides regulatory labeling support including QC of labeling documents, artwork QC, translations management, and labeling project coordination.
  • Perform quality checks in accordance with local labeling requirements (EU, US, and ROW).
  • Manage electronic and physical labeling repositories.
  • Prepares communications for approved/effective product labeling to key stakeholders.
  • Prepare drug listing and establishment registrations for the US.
  • 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.

EXPERIENCE

Required Skills:

5 - 7 Years with BA

3 - 5 Years with Masters,

with 2-4 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
  • Experience with global labeling processes and management application of Company Core Data Sheets
  • Experience in review process, standards, and industry best practice pertaining to labeling
  • Strong scientific background and/or experience to quickly establish therapeutic area working knowledge
  • Experience with implementation of labeling components into manufacturing process
  • 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
  • Experienced processing and assessing translations of labeling a plus
  • 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
  • Thorough understanding of regulatory labeling requirements
  • Flexibility to work occasional nights and weekends as determined by critical Regulatory deadlines.

Desired Skills:

  • International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable.

EDUCATION

Minimum requirements a four-year degree, preferably in life sciences.

SUPERVISOR RESPONSIBILITY

This position does not have direct reports.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.