Regulatory Affairs Associate Director

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:

[Regulatory Expertise]

• Provide regulatory leadership, expertise & value by developing regulatory strategies in close collaboration with the Global Regulatory Lead (GRL) and China core team. This role aims to accelerate the submission, approval & launch of the responsible projects or sub-TA portfolio, to improve patient outcomes in China.

• Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through partnership with RDE & project core teams. Ensure product registration and other regulatory affairs activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations.

• Interact with regulatory authorities and timely communicate with Lilly internal functions of product registration issues.

• Lead the development of labelling strategy (product information and packaging) 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 China. Lead team during negotiation with regulators by providing responses to labeling questions.

• Monitor and evaluate the new regulations and guidance, regulatory changes and trends, and work with internal regulatory intelligence & policy group to provide business insights.

• Support China regulatory environmental shaping efforts.

• Cross-functional collaboration:

  • Collaborate closely with China project teams on developing development scenarios and making team recommendations
  • Work closely with GRLs to ensure that China needs are fully integrated into the global development plan
  • Provide input and advice on new product launch plans in terms of regulatory requirements.
  • Collaborate with related functions to ensure market supply sufficiency, artwork and labeling comply with agency requirement and marketing promotion needs.

[Lead, influence and partner]

• Partner with GRLs to help solve development and regulatory issues impacting local registrations and engaging with business unit and development team on assigned projects.

• Partner with GRLs to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for China.

• Anticipate China specific issues, impact of labelling on promotion, pricing, and reimbursement.

• Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.

• Propose continuous improvement projects to simplify processes and increase productivity of work

• Lead or represent the regulatory function on cross-functional non-product related projects

• Serve as a mentor for China RA personnel.

• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.

• Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.

• Create and lead in an environment of equity and inclusion that encourages open discussions on issues to achieve a robust outcome on business decisions.

Minimum Qualification Requirements:

• At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences

• At least 8-years experiences in drug regulatory affairs

• Demonstrated knowledge and ability in leading the new technology or platform, if the position is for a novel technology

• Demonstrated knowledge of the drug development process, Lilly’s (or external peer company) regulatory/business strategies

• Demonstrated ability to assess and manage risks in a highly regulated environment

• Demonstrated strong written, spoken and presentation communication both in Chinese and English

• Demonstrated negotiation and influence skills

• Demonstrated attention to details

• Self-motivated and Innovative

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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