Global Regulatory Affairs - Global Labelling - Spanish Multi Market Labeling Coordinator at Eli Lilly and Company

Sao Paulo, Sao Paulo, Brazil

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Thorough understanding of the labeling implementation process and its impact
Up-to-date knowledge of submission statuses, requirements, and conditions of MML markets
Knowledge of business processes and labelling to gain alignment with partners on standardized processes and labelling deliverables
Ability to recognize complex labelling scenarios, identify potential solutions, and escalate when necessary
Ability to process information and team/audience dynamics and adapt style when negotiating with cross-functional partners

Responsibilities

Serve as a labelling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labelling for new and marketed products
Support labeling development executed by external partners holding local product licenses of Lilly manufactured products on their own behalf
Act as a delegate for Affiliate labelling responsible person (ALRP) outlined in the Labelling Development and Maintenance standard
Liaise closely with GRA Regional Regulatory Scientists and Manufacturing/Supply Chain on the creation of new MML to support product launch
Manage ARF and Truth/Proof Process including any needed translations to create new and updated MMLs and provide required submission documents to affiliate ALRPs and/or External Partner
Drive the maintenance of marketed product MML in line with reference label, internal timelines and bundling decisions
Monitor, support and drive the implementation of updated or new labelling components into the market
Maintain the MML strategic plan
Monitor reference country product labels for planned implementation in MML
Network with global manufacturing site functions such as Supply Chain, Manufacturing, Regulatory and Printing, Packaging and Development to develop labelling materials, acquire submission documents and plan, and manage MML production decisions
Create Veeva Vault RIM entries when needed for each impacted market for planning, tracking and status reporting purposes and ensure that data in Veeva Vault RIM and BLUE are accurate at all times
Provide ALRP and external partner training including the use of Veeva Vault RIM and BLUE to ensure accurate data capture

Skills

Key technologies and capabilities for this role

Regulatory AffairsGlobal LabellingSpanish Multi Market LabellingSP-MMLRegulatory SubmissionsPackaging DevelopmentCross-Functional CoordinationLabeling Implementation

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key skills or experiences are required for the Spanish Multi Market Labeling Coordinator role?

The role requires serving as a labelling resource for regulatory strategies, supporting labeling development by external partners, acting as a delegate for Affiliate labelling responsible person (ALRP), liaising with GRA Regional Regulatory Scientists and Manufacturing/Supply Chain, and managing ARF and Truth/Proof Process including translations.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and looks for determined individuals who give their best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Global Regulatory Affairs role?

Strong candidates demonstrate a thorough understanding of the labeling implementation process, drive timely submissions and implementations, communicate implications of labeling changes to cross-functional partners, and develop efficient bundling plans.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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