Regulatory Affairs Manager at Eli Lilly and Company

Petaling Jaya, Selangor, Malaysia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree or equivalent in a relevant scientific subject
Team working skills with special focus on results
Ability to adapt to challenging situations
Demonstrated good computer/IT skills
Good knowledge of written and spoken English
Analytical, problem solving and negotiation skills
Good communication skills
Project management skills
Strong knowledge of quality systems

Responsibilities

Manage regulatory operational and technical aspects on company’s behalf for business partners who are marketing authorization holders
Align on submission plans, monitor progress and provide support as necessary
Ensure timely provision of required submission dossiers to business partners
Foster an environment of operational excellence and liaise cross-functionally on regulatory strategy
Oversee labelling projects to ensure new and updated labelling are implemented timely
Build and maintain strong working relationships with business partners
Follow-up on application progress and periodically review business partner performance metrics
Serve as regulatory point person for any regulatory queries from internal and external stakeholders
Ensure business contracts are current and valid
Responsible for the execution of third party management activities
Coach Regulatory Associates on third party oversight and establish metrics
Collaborate with business partners to ensure timely and clear dossier requirements during submission planning
Liaise cross-functionally with internal and external stakeholders to agree on regulatory strategy
Facilitate implementation of the regulatory plan
Obtain all required submission documents and ensure timely responses to Regulatory Authority requests
Ensure documents meet requirements or use regulatory expertise to provide creative solutions if unable to meet requirements
Ensure provision of submission documents to business partner per contract timelines
Ensure archiving of electronic copies of applications
Ensure data maintenance and data integrity of regulatory systems with defined compliance metrics
Ensure implementation of local quality system in line with the global quality system
Ensure audit and inspections readiness
Effective issue management and implement corrective/preventive actions as appropriate
Perform the role of a labelling responsible person
Ensuring that product information complies with company core data sheet
Liaise with stakeholders to ensure timely implementation of label changes
Ensure alignment and implementation of internal regulatory initiatives

Skills

Regulatory Submissions

Dossier Management

Labelling Compliance

Business Partner Oversight

Third Party Management

Regulatory Strategy

Cross-functional Collaboration

Submission Planning

Regulatory Queries

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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