Sr Regulatory Affairs Manager- DIA

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.

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.

-- Provide regulatory expertise to propose China registration strategy through working closely with China and global study team and get alignment. Implement, review and update regulatory strategy when necessary.

-- Ensure product registration related activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations.

-- Oversee the progress and ensure product registration approval.

• Review product registration strategy and action plan. Timely make recommendations to adjust the strategy to related functions and communicate with GRA (Global Regulatory Affairs) and China internal departments for the major changes and rationale.
• Review and sign registration dossier and other regulatory documents to ensure the data presented fully represent what is practically required.
• Timely communicate with regulatory authorities to get regulatory feedback.
• Timely review and communicate registration progress and issues with related functions; provide direction, guidance, and support as needed in analysis and/or solution of the issues.

-- Cross-functional collaboration

• Provide input and advice on the new product launch plan in terms of regulatory requirement.
• Collaborate with related functions to ensure market supply, artwork and labeling comply with agency requirement.

-- Provide supervision on dedicated TA team, engage, retain and grow junior RA colleagues (when applicable).

-- Participate in development and review of RA SOP and other RA functional system.

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

-- Perform the function of delegate ALRP role:

• Product Information should comply with local reg requirements, and the updated Product Information should be submitted, approved and implemented within the designated internal and/or MOH timelines.
• Follow global labelling procedures, and document relevant exceptions in order to produce accurate and high-quality Product Information which is in compliance with global core labeling.

-- Perform ad hoc projects or assignments.

Minimum Qualification Requirements:  

• At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences
• At least 5-year experience in drug regulatory affairs with at least 3-year experience in global leading pharmaceutical company
• Good skill on English writing, speaking and listening
• Good skill on computer operation
• Self-motivated and Innovative
• Leadership 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.