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Jobs or company...

Regulatory Affairs Manager / Senior Manager

Salary undisclosed
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Manage regulatory operational and technical aspects on company’s behalf for the 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 revised labelling are implemented timely

Partner Collaboration and Oversight

  • 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

Regulatory Planning

  • 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

Dossier Management

  • 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

Regulatory Compliance

  • 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

Labelling

  • Perform the role of a labelling responsible person
  • Ensuring that product information complies with company core data sheet
  • Liase with Supply Chain to ensure timely implementation of label changes

Process Improvement

  • Ensure alignment and implementation of internal regulatory initiatives

Minimum Qualification Requirements:

  • Bachelor's degree or equivalent in a relevant scientific subject
  • At least one year industry related experience in Regulatory Affairs
  • 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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly