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.
At Eli Lilly Cork, 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 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you can also count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory Expertise for Assigned Program/Product(s) in Region/Country
- Provide region/country input and review of global strategic plans and global/regional submission plan and documents.
- Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
- Ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners in contributing to development of submission content.
- 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.
- 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.
- Ensure compliance with all applicable regulations and internal quality systems.
- Provide up-to-date expertise on regional registration procedures.
- Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
- Own all regulatory activities in support of assigned marketed product(s) in the region/country.
For regional regulatory scientist supporting the US:
- Set appropriate direction with Global Marketing and US Brand Team for development, review, and approval of promotional claims.
- Partner with GRA-Product Communications reviewer to advise US Brand Team on promotional strategy
For regional regulatory scientist supporting Asia Pacific
- Ensure the local regulatory requirements in AP countries are communicated to development and CMC teams for incorporation into molecule development programs
- Ensure the registration needs for local patients in clinical trials are met for countries in the region/country
For regional regulatory scientist supporting for EMEA:
- 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).
- Ensure the registration needs for local patients in clinical trials are met for countries in the region/country
Lead, influence and partner
- 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.
- Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned region.
- Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing, and reimbursement.
- Participate in regional meetings (commercial managers, medical directors) to ensure that regulatory strategy and issues are considered and to learn about their needs.
- Participate in forums that regulatory information across GRA components and other Lilly teams and business partners.
- Propose continuous improvement projects to simplify processes and increase productivity of work executed by affiliates and GRA
- Lead or represent the regulatory function on cross-functional non-product related projects
- Serve as a mentor for GRA 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.
- Constructively challenge teams to reach the best solutions to issues.
- 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:
- Bachelor’s degree in a scientific or health sciences discipline
- Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years
- Knowledge of local/regional regulatory procedures and practices
- Awareness of evolving regulatory reform initiatives, preferred
- Demonstrated knowledge of the drug development process, Lilly’s (or external peer company) regulatory/business strategies
- Demonstrated ability to find solutions and alternatives through teamwork, embracing diversity, equity and inclusion, resulting in positive business outcomes
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Demonstrated strong written, spoken and presentation communication
- Demonstrated negotiation and influence skills
- Demonstrated attention to detail
Other Information/Additional Preferences:
- Industry-related experience in regulatory affairs and/or drug development experience for 5 years (preferred)
- Local language proficiency is desirable, dependent on the region.
- Location: preferably in the region of support; preferably at a Lilly/LRL site
- Key Contacts: Project team members, Global Regulatory Leads and other global regulatory team members, regional marketing/medical, and affiliate regulatory representatives
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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