Senior Manager / Manager, Regulatory Affairs, Hong Kong and Macau

JOB DESCRIPTION

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.

Purpose :

The purpose of the Sr. Manager / Manager, GRA Regional Regulatory, Affiliate Regulatory role is to manage all aspects of regulatory affairs for the marketing affiliate -Hong Kong and Macau, including :

• Ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements (whichever is more stringent).
• Foster an environment of operational excellence through regulatory expertise and, if relevant, managing and developing direct reports and collaborating with cross-functional teams to successfully achieve Affiliate regulatory objectives.
• Facilitate and cultivate external relationships with the relevant Government bodies and industry associations.

Primary Responsibilities : This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory Strategy

Preparation and support of new applications to obtain marketing authorizations.

Regulatory Compliance

Labelling

Process Improvement

Personal and Professional Development

Minimum Qualification Requirements :

Other Information / Additional Preferences :

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 (

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

Explore Location Close the popup

Apply Now Save job