Associate Director/Director, GRA-EMEA
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 Associate Director/Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist is accountable for the below;
Primary Responsibilities:
Providing Regulatory Expertise for Assigned Program/Product(s) in Region/Country
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.
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).
Lead, influence and partner;
Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing, and reimbursement.
Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
Minimum Qualification Requirements
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.
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.
