Associate, Clinical Regulatory Scientist at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in regulatory affairs to manage all aspects for the marketing affiliate
Ability to supervise the Regulatory Affairs Department
Capability to develop and implement regulatory plans and strategies aligned with affiliate business plans and regulatory requirements
Skills in preparing and supporting high-quality regulatory applications for submissions and approvals within timelines
Experience in maintaining clear metrics for regulatory deliverables
Proficiency in voicing affiliate perspectives to global and regional regulatory contacts
Competence in ensuring timely responses to requests from support groups and/or Regulatory Authorities
Knowledge of maintaining marketing authorizations through timely post-approval activities (e.g., renewals, variations)

Responsibilities

Supervise the Regulatory Affairs Department to ensure success of new product registrations, line extensions, and new indications in alignment with the affiliate business plan
Maintain compliance for all products with local regulations and quality system requirements (whichever is more stringent)
Foster an environment of operational excellence through regulatory expertise, managing and developing direct reports (if relevant), and collaborating with cross-functional teams
Facilitate and cultivate external relationships with relevant Government bodies and industry associations
Develop and implement the Regulatory Plan and Strategy in alignment with affiliate business plans and regulatory requirements
Ensure submission and approval of high-quality regulatory applications within planned timelines
Prepare and support new applications to obtain marketing authorizations
Voice affiliate perspective and needs to global and regional regulatory contacts
Ensure timely responses to requests from support groups and/or Regulatory Authorities
Maintain marketing authorizations through timely submission of post-approval maintenance activities (e.g., renewals, variations)

Skills

Clinical Regulatory

Regulatory Affairs

Clinical Trials

Healthcare Compliance

Pharmaceutical Regulations

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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