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.

The purpose of the Ex. Director/Sr. Director Global Regulatory Affairs (GRA) Capabilities and Execution lead is to drive strategic leadership, business transformation, and functional operations required to ensure the GRA-AP organization delivers to its mission. The Ex. Director/Sr. Director will serve as a senior advisor to the Vice President/AVP of GRA-AP on all matters of business transformation and regulatory excellence leading our people, processes, and technology capabilities to enable robust organizational effectiveness. This person, in partnership with the GRA leadership team, will be responsible for overall functional operations and leading the implementation of sanctioned GRA business transformation activities.

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.

1. GRA Capabilities and Execution Lead responsibilities:
Advise and assist Vice President/AVP of GRA-AP on all matters related to business transformation, strategic planning, business operations and resource management.

Partner with Vice President/AVP of GRA-AP on leadership staff meeting agendas and functional town halls to ensure effective linkages of business activities and communications to improve employee engagement.

Partner with MQO on GRA Quality Lead Team meeting agendas to provide quality and compliance oversight of systems, processes, procedures, and cross-component initiatives and ensure an environment of continuous improvement while meeting changing regulatory expectations

Lead the execution of the strategies and priorities for the regional GRA-AP team and drive a consistent focus on achieving high standards for regulatory capabilities and prioritization of key deliverables

Assess GRA performance by executing feedback surveys with business partners

Establish and maintain process, in partnership with human resources, for functional-level talent identification, reviews and retention.

Provide regional management of GRA onboarding program, including training curricula and job descriptions

Advocate for opportunities to share learning and streamline access to regulatory information and resources for GRA-AP employees

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

2. Lead Implementation of GRA Business Transformation

Drive strategies, in partnership with GRA-AP and cross functional leaders, to develop plans for transformation projects

Provide oversight of regional execution and implementation of plans for transformation projects

Provide oversight and ensure coordination of communications derived from transformation projects

Promote a culture that fosters innovation and seeks to continually improve regulatory excellence and operational excellence

3. People Excellence

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

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

Help to recruit, develop, and retain a capable workforce with regulatory processes and system knowledge to effectively interact with teams

Support an agile organization that continuously meets the needs of an effective regulatory business operation to support the portfolio

Create contingency plans for future staffing models that address how work could be done differently given changes in resource allocation, staffing models, etc

Coach, develop, and mentor leaders within the GRA – AP organization

Create an environment where employees motivate themselves

Support a diverse organization that fosters inclusion and innovation

4. Operational Excellence

Assure robust processes and technology are in place that enable meeting regulatory requirements within the region.

Assure quality systems are in place and include performance and quality metrics, to enable compliance

Assure processes and technology are evaluated at regular intervals and that improvement activities are conducted as needed

Provide necessary leadership to ensure functional strategies are flexible to adapt to changing business needs and changes in regulations

Ensure engagement in industry forums to assure Lilly is aware and implementing best practices

Lead team through ambiguity and take into consideration unique requirements by business, function, or geography, while also driving home solutions that can be standardized, centralized, and automated

Minimum Qualification Requirements:
Advanced degree (Ph.D., M.D, or Pharm.D.) or Bachelor’s degree with adequate professional experience to meet above deliverables

10 years of experience in the pharmaceutical industry with experience in regulatory affairs, product development and commercialization

Strong business acumen with demonstrated success in business transformation

Strong knowledge of regulatory procedures and practices

Knowledge of product development process, commercialization, and regulatory/business strategies

Demonstrated leadership skills and effectiveness in the areas of influence, team leadership, articulating and taking a position, negotiation, and conflict resolution

Effective team building capabilities

Strong written, spoken and presentation communication in English. Chinese, Korean and Japanese language fluency desirable.

Other Information/Additional Preferences:
Six Sigma experience

Project management experience

Travel expected (15-20%)

Location: Singapore

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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