Regulatory Affairs Expert

3 weeks ago

Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time
About the Job

We are seeking an experienced Regulatory Affairs Expert to join our team at Eli Lilly and Company. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring that our pharmaceutical products meet regulatory requirements and are approved for marketing in various regions.

Job Summary

The Associate Director/Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist is accountable for establishing local regulatory strategies and plans for assigned products in the EMEA region, ensuring alignment with global regulatory strategies and compliance with local regulations and business needs.

Key Responsibilities
  1. To establish local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included.
  2. To provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s).
  3. May perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.
    1. Providing Regulatory Expertise for Assigned Program/Product(s) in Region/Country
    2. Region/country input and review of global strategic plans and global/regional submission plan and documents.
    3. Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
    4. Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content.
    5. 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/country.
    6. Ensure compliance with all applicable regulations and internal quality systems.
    7. Own all regulatory activities in support of assigned marketed product(s) in the region/country.
    8. Be involved in medical device/in-vitro diagnostics regulatory activities and to potentially serve as, or perform the responsibilities of, the medical device UK Responsible Person or EU Authorized Representative in accordance with applicable UK or EU legislation, respectively, and the associated internal Quality Agreement(s).
    9. Ensure the registration needs for local patients in clinical trials are met for countries in the region/country.
Requirements
  1. Bachelor's degree in scientific or health sciences discipline.
  2. Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5 years.
  3. Knowledge of local/regional regulatory procedures and practices.
  4. Awareness of evolving regulatory reform initiatives, preferred.
  5. Demonstrated knowledge of the drug development process, Lilly's (or external peer company) regulatory/business strategies.
  6. Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes.
  7. Demonstrated ability to assess and manage risk in a highly regulated environment.

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