Senior Associate, Global Labelling Regulatory Affairs
Description
Who We Are
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.
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.
Senior Associate, Global Labelling Operations - Regulatory Affairs - London
Hybrid (2 days per week onsite in Central London)
SUMMARY
This position is responsible for supporting the development, review, and management of US, EU, and international labelling artwork components for commercial products. Responsible for QC assessment and managing labelling changes for lifecycle products and support of new labelling for new market applications. 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 documents, translations, and verification of translations, and tracking project milestones and status.
RESPONSIBILITIES
This position will be responsible for:
Labelling Processes Development, Artwork Management and Labelling Requirements
- Initiate artwork requests and requirements for implementation of new or revised labelling components via the artwork management system (GLAMS)
- Manage implementation requirements worldwide
- Provide input to internal tracking systems/databases to control workflow and ensure labelling projects/submissions and implementation deadlines are met
- Assist with regulatory research supporting labelling activities
- Communicate with labelling managers to ensure any new regulatory requirements are incorporated into the labelling documents
- Work with Packaging Operations and Supply Chain to facilitate implementation of labelling for printed packaging components.
- Monitoring launch and/or release of revised labelling into production.
- Ensuring the highest quality for preparation of labelling content, components, and supporting documentation.
- Launch/Implementation: Review final artworks approve new or revised labelling to be implemented into production. Approve all change requests for revised labelling for assigned projects/products. Provide Supply Chain and QA guidance on labelling implementation requirements. Support first launch into new markets.
Review and prepare labelling documents
- Provides regulatory labelling support including QC of labelling documents, artwork QC, translations management, and labelling project coordination.
- Perform quality checks in accordance with local labelling requirements (EU, US, and ROW).
- Manage electronic and physical labelling repositories.
- Prepare communications for approved/effective product labelling to key stakeholders.
- Prepare drug listing and establishment registrations for the US.
- Contribute to global labelling 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:
2-4 years in Regulatory Affairs with experience managing labelling submissions and artwork
- US and/or EU Labelling experience minimally required and core labelling experience highly desired
- Experience and working knowledge with SPL and PLR requirements and/or SmPC/PIL and QRD requirements
- Experience with global labelling processes and management application of Company Core Data Sheets
- Experience in Veeva RIM and Artwork Management systems
- Experience in review process, standards, and industry best practice pertaining to labelling
- Experience with the implementation of labelling components into the manufacturing process
- Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labelling
- Experienced processing and assessing translations of labelling 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 labelling requirements
Desired Skills:
- International labelling experience including Latin America, APAC Regions, and EEAM/MEA Regions desirable.
EDUCATION
Minimum qualification: a degree, preferably in life sciences.
SUPERVISOR RESPONSIBILITY
This position does not have direct reports.
LOCATION
Hybrid work requiring 2 days onsite per week in London.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.