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:

As senior individual staff, besides handle daily regulatory works, the purpose of Associate Director role is to play SME role in specific area, support project team on RA strategy design, technically shadow P1-P3 employees, shape regulatory environment by participating TFs and leading discussion.

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.

As a SME in specific area, provide technical leadership and manage regulatory to deliver expected regulatory and business outcomes.

Deep technical expertise in specific area as SME

Support TA head to make robust regulatory strategy and manage regulatory interactions with NMPA/CDE

Help team to build up new knowledge and capability in specific area

Technically shadow P1-P3 RA colleagues and help them grow up (when applicable), especially in SME area.

Provide technical consulting and advice to P1-P3 RA colleagues across projects

Help review submission documents for junior colleagues to ensure good quality.

Actively participate and lead activities to shape regulatory environment, especially in SME area.

Establish and maintain a good relationship with key stakeholders, and grasp up-to-date regulatory trends and reflect them to regulatory strategy & plan

Actively participate and lead regulatory environment shaping by leveraging industry platforms (e.g. RDPAC, DIA, CMAC, ISPE)

As part of responsibility, handle project registration and regulatory daily work independently

Ensure compliance with company policies, principles & procedures which China local team is trained on these aspects.

Minimum Qualification Requirements:  

At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences, master most preferredAt least >10 year experience in drug regulatory affairs with at least 5-year experience in global leading pharmaceutical companyGood skill on English writing, speaking and listeningGood skill on computer operationSelf-motivated and InnovativeLeadership with people management/general management training (preferable).

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

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