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Manager/Sr. Manager-Regulatory Affairs

5+ years
Not Disclosed
10 Jan. 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Us at Lilly: Regulatory Affairs Manager

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and contribute to communities through philanthropy and volunteerism. We're looking for individuals committed to improving lives globally.

Job Title: Regulatory Affairs Manager
Location: [Location]
Reports to: [Manager/Supervisor]

Purpose:
This role involves regulatory planning and ensuring compliance with regulatory requirements for new products (including product line extensions) and new indications. You'll be responsible for maintaining regulatory compliance for marketed products, including variations, renewals, and pharmacovigilance activities. You'll also build partnerships with officials in the regulatory authority and keep up-to-date on changes in both local and global regulatory environments.

Primary Responsibilities:

  1. Regulatory Planning

    • Regulatory Plan Development: Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products. Ensure alignment with the business plan.
    • Process Management: Coordinate cross-functional teams to ensure timely availability of required documents for dossier preparation.
    • Regulatory Tools: Update and maintain data in regulatory tools to ensure accurate communication to relevant stakeholders.
  2. Submissions and Approvals

    • Dossier Preparation: Prepare and submit quality regulatory dossiers within the affiliate timelines.
    • Gain Regulatory Approval: Obtain Drug Regulatory Agency approvals to support product launch and ensure compliance with local label creation and packaging requirements.
    • Metrics Review: Prepare and communicate regulatory performance metrics.
  3. Regulatory Compliance

    • Maintain compliance for marketed products through regulatory audits and self-checks. Address any compliance issues related to labeling, pharmacovigilance, and more.
    • Implement Good Regulatory Practices (GRP) and stay updated with local and global regulations.
  4. Regulatory Influence

    • External: Build relationships with key regulatory officials to foster a positive regulatory environment.
    • Internal: Collaborate with the affiliate team to integrate regulatory input into decision-making processes.
  5. Additional Responsibilities (If applicable)

    • Support health economic data for price negotiations, clinical trials, and locally manufactured products.

Minimum Qualifications:

  • Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, or related field (MD preferred in applicable countries).
  • Minimum 3 years of experience in regulatory affairs or a related field.
  • Strong knowledge of local and global regulations for pharmaceutical product registrations.

Additional Preferences:

  • Excellent communication and interpersonal skills.
  • Strong project management and multitasking abilities.
  • Analytical thinking, problem-solving, and customer-focused approach.

Lilly is committed to diversity and inclusion. We ensure equal opportunities for individuals with disabilities and offer reasonable accommodation during the application process. For assistance, please complete the accommodation request form.

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

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