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.
Overall purpose:
The Associate Director/Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist is accountable for the below:
1. To establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included.
2. To provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s).
3. Responsible for leading meetings and other interactions with region/country regulators.
4. May perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.
Primary Responsibilities:
1. Providing Regulatory Expertise for Assigned Program/Product(s) in Region/Country
2. Region/country input and review of global strategic plans and global/regional submission plan and documents.
3. Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
4. Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content.
5. Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Influence the regulator in favor of the planned development.
6. Lead development of local/regional labelling strategy (product information and packaging) and network for alignment across region/affiliate team 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 region/country. Lead team during negotiation with regulators by providing responses to labeling questions.
7. Ensure compliance with all applicable regulations and internal quality systems.
8. Provide up-to-date expertise on regional registration procedures.
9. Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
10. Own all regulatory activities in support of assigned marketed product(s) in the region/country.
11. Be involved in medical device/in-vitro diagnostics regulatory activities and to potentially serve as, or perform the responsibilities of, the medical device UK Responsible Person or EU Authorized Representative in accordance with applicable UK or EU legislation, respectively, and the associated internal Quality Agreement(s).
12. Ensure the registration needs for local patients in clinical trials are met for countries in the region/country.
Lead, influence and partner:
1. Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations and when engaging with relevant business unit and development team on assigned programs/products.
2. Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned region.
3. Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing, and reimbursement.
4. Participate in regional meetings (commercial managers, medical directors) to ensure that regulatory strategy and issues are considered and to learn about their needs.
5. Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.
6. Propose continuous improvement projects to simplify processes and increase productivity of work executed by affiliates and GRA.
7. Lead or represent the regulatory function on cross-functional non-product related projects.
8. Serve as a mentor for GRA personnel.
9. Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
10. Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
11. Constructively challenge teams to reach the best solutions to issues.
12. 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:
1. Bachelor’s degree in scientific or health sciences discipline.
2. Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5 years.
3. Knowledge of local/regional regulatory procedures and practices.
4. Awareness of evolving regulatory reform initiatives, preferred.
5. Demonstrated knowledge of the drug development process, Lilly’s (or external peer company) regulatory/business strategies.
6. Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes.
7. Demonstrated ability to assess and manage risk in a highly regulated environment.
8. Demonstrated strong written, spoken and presentation communication.
9. Demonstrated negotiation and influence skills.
10. Demonstrated attention to detail.
Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.
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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.
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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