Manager/Sr Manager, Regulatory Global Labeling
Location: San Rafael
Posted on: June 8, 2021
Manager/Sr Manager, Regulatory Global Labeling
Location San Rafael, California Apply
Position: Manager/Sr Manager, Regulatory Global Labeling
This position will be responsible for leading thedevelopment,
review, and management of US, EU, and International labeling for
commercial products. The incumbent will beresponsible 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) (Manager or Senior Manager based on level of
experience) 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.
This position will be responsible for:
- 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
- Review worldwide labeling against the Core Safety Information
and facilitate and track implementation of changes to align with
- 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
- 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
- Supporting launch and/or release of revised labeling into
Regulatory Labeling Strategy:
- 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 REGGL 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
- Provide input on interpretation and implementation of key
regional labeling regulations, guidelines, and best labeling
Regulatory Labeling Activities:
- Document control and distribution of product labels
(prescribing information, carton and container labeling) including
drafting initial documents, annotations, generate and review of SPL
files, prepare final labeling.
- Project management role of logistical activities and delivering
labeling documents within agreed timeframes. Global Product
Information: 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
- Interactions with RA worldwide: 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.
- Regulatory Reporting: Provide RA input to Periodic Safety
Update Report (PSUR) and Annual Reports for assigned products.
- 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
Excellence and Compliance:
- Contribute to global labeling management and continuous
improvement initiatives. Review and comment on emerging internal
and external guidelines and regulations on regulatory, safety, and
- Ensure compliance with global regulatory requirements and
adherence to regulatory internal policies and processes.
4-6 years, 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
- 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
- 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
- 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
- Ability to travel (up to 15%) for industry conferences or other
- Flexibility to work occasional nights and weekends as
determined by critical Regulatory deadlines
- International labeling experience including Latin America, APAC
Regions, and MENA CIS Regionsdesirable.
Minimum requirements BS or MS with requisite experience and
demonstrated capability. Science or medical background and advanced
degree (MD, Ph D, PharmD) desirable.
This position does not have direct reports.
Keywords: Biomarin, San Rafael , Manager/Sr Manager, Regulatory Global Labeling, Other , San Rafael, California
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