Senior Associate, GRA Regional Regulatory, Affiliate at Eli Lilly and Company

Bogotá, Bogota, Colombia

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment
Ensure knowledge of local regulations and quality system requirements
Collaborate with cross-functional teams and foster operational excellence
Facilitate and cultivate relationships with local regulatory agencies/MoH
Represent Regulatory Affairs in Affiliate Lead Team and New Product Planning discussions
Provide regulatory quality oversight for Third Parties (e.g., Regulatory Services Providers, Translators, Graphic Agencies)

Responsibilities

Execute the Regulatory Plan to ensure success of new product registration, line extensions, and new indications in alignment with affiliate business plan, while maintaining compliance
Implement the Regulatory Plan in alignment with affiliate business plans and regulatory requirements
Ensure submission and approval of high-quality regulatory applications within planned timelines, including preparation of new applications for 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 activities (e.g., renewals, variations, periodic reports)
Maintain Regulatory Tools in alignment with defined compliance metrics
Support Affiliate launch Teams by anticipating regulatory constraints and delivering outcomes to support launch plans
Facilitate interactions with regulatory bodies on a regular basis
Ensure internal Regulatory IT tools are up to date and accurate
Ensure all products comply with local regulations and quality system requirements (whichever is more stringent)
Ensure regulatory archive is complete and up-to-date, with current licenses and labels readily available
Ensure implementation of local quality system in line with global quality system and local regulations
Support internal and external audits, assessments, and self-inspections in collaboration with Regulatory Quality personnel
Implement corrective/preventive actions as appropriate
Raise awareness to leadership and relevant functions on compliance issues and initiatives, and provide technical support to other affiliate functions
Perform labelling functions (incomplete in description)

Skills

Regulatory Affairs

Regulatory Plan Execution

Product Registration

Line Extensions

New Indications

Compliance

Regulatory Submissions

Local Regulations

Quality Systems

Cross-Functional Collaboration

Regulatory Agency Relationships

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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