Lilly is seeking a Senior Regulatory Affairs Associate to join our team. This role is responsible for managing the operational and technical aspects of regulatory affairs for our marketing affiliate, ensuring new product registration and maintaining compliance for all products.
What You'll Do
- Execute the Regulatory Plan to ensure the success of new product registration, line extensions, and new indications in alignment with the affiliate business plan.
- Maintain compliance for all products with local regulations and quality system requirements.
- Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve affiliate regulatory objectives.
- Facilitate and cultivate relationships with the local regulatory agency or Ministry of Health.
- Own and manage responsibilities in Regulatory Plan Execution, Regulatory Compliance, Labelling, Process Improvement, and Personal and Professional Development.
What We're Looking For
- Proven experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of regional/local regulatory processes.
- Demonstrated ability to execute regulatory strategies and plans for product registrations and lifecycle management.
- Strong knowledge of local regulations and quality system requirements relevant to pharmaceutical products.
- Excellent collaboration skills with experience working effectively in cross-functional teams.
- Experience in liaising and building relationships with local regulatory authorities.
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.
