Associate Director - Regional Regulatory-Americas at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Regulatory expertise for assigned program/product(s) in Americas Region (US, CA, LATAM)
Ability to provide region/country input and review of global strategic plans and global/regional submission plans and documents
Capability to contribute during key governance committees to regional regulatory strategy decisions (e.g., when key discussion topics impact the region)
Skills to ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners
Experience owning relationships and leading meetings/interactions with regulators in assigned region, engaging cross-functional partners
Ability to influence regulators in favor of planned development
Expertise in leading development of local/regional labelling strategy (product information and packaging)
Knowledge to network for alignment across region/affiliate team to enable timely completion of registration milestones (submission, approval, launch)
Application of labelling expertise, competitor knowledge, and regulatory precedent to propose commercially viable labelling content

Responsibilities

Provide region/country input and review of global strategic plans and global/regional submission plan and documents
Contribute during key governance committees to regional regulatory strategy decisions, if requested (e.g., when key discussion topics impact the region)
Ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners in contributing to development of submission content
Own relationship and lead meetings and interactions with regulators in assigned region and engage cross-functional partners to contribute to regulator interactions; influence the regulator in favor of the planned development
Lead development of local/regional labelling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e., submission, approval, and launch)
Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region

Skills

Key technologies and capabilities for this role

Regulatory AffairsPharmaceuticalsComplianceAmericas RegulationsHealthcare Policy

Questions & Answers

Common questions about this position

What benefits does Eli Lilly Cork offer?

Eli Lilly Cork offers flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, on-site parking, Inhouse People Development services, Educational Assistance, and ‘Live Your BEST Life’ wellbeing initiatives.

Is this a remote or hybrid role?

The role offers flexible hybrid working options from the campus in Little Island.

What is the company culture like at Eli Lilly Cork?

Eli Lilly Cork features a talented diverse team of over 2,000 employees across 60 nationalities, with a strong commitment to diversity, equity, and inclusion through pillars like EnAble, Age & Culture, LGBTQ+, and GIN-Gender Inclusion Network, encouraging employees to Be Creative, Be an Innovator, and Be Yourself.

What skills or expertise are needed for this role?

The role requires regulatory expertise for assigned programs/products in the Americas region, including the US, CA, and LATAM, with the ability to provide region/country input and review of global strategies.

What makes a strong candidate for this position?

Strong candidates align with Lilly's purpose of making life better through discovery and innovation, thrive in a diverse and inclusive team environment, and bring regulatory expertise for the Americas region.

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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