Senior Regulatory Affairs Associate at Eli Lilly and Company

Sydney, New South Wales, Australia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Ability to manage operational and technical aspects of regulatory affairs for a marketing affiliate
Expertise in executing Regulatory Plans for new product registrations, line extensions, and new indications in alignment with affiliate business plans
Knowledge of maintaining compliance with local regulations and quality system requirements
Skills in fostering operational excellence and collaborating with cross-functional teams to achieve regulatory objectives
Capability to facilitate and cultivate relationships with local regulatory agencies/Ministry of Health

Responsibilities

Execute the Regulatory Plan to ensure success of new product registration, line extensions, and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements
Foster an environment of operational excellence and collaborate with cross-functional teams to achieve Affiliate regulatory objectives
Facilitate and cultivate relationships with the local regulatory agency/MoH
Manage Regulatory Plan Execution
Ensure Regulatory Compliance
Handle Labelling
Drive Process Improvement
Engage in Personal and Professional Development

Skills

Regulatory Affairs

Regulatory Plan Execution

Product Registration

Line Extensions

New Indications

Regulatory Compliance

Labelling

Process Improvement

Cross-Functional Collaboration

Regulatory Agency Relations

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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