Associate - GRA Regional Regulatory Affairs, UK Affiliate

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.

ABOUT LILLY:

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Role overview

As the GRA Regional Regulatory Affairs Associate you will complete the operational aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, including:

1. License maintenance activities (e.g. Labelling changes, CMC changes, Renewals)
2. New marketing authorisations, line extensions and new indications
3. Tracking regulatory procedures and filing/archiving correspondence in accordance with local regulations and quality system requirements

Responsibilities include:

Regulatory Plan Execution

1. Collaborate with the implementation of the regulatory plan/objectives in alignment with affiliate business plans as well as with regulatory requirements.
2. Support submission of high quality regulatory applications within planned timeframes.
3. Support dossier preparation of new applications to obtain marketing authorisations.
4. Coordinate administrative tasks (e.g. payments, legalisations).
5. Execute maintenance activities for marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports).

Labelling

1. Perform the function of Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or regulatory authority timeframes.
2. Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labelling.

Regulatory Compliance

1. Keep internal regulatory IT tools and trackers up to date and accurate.
2. Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
3. Keep regulatory archives complete and up to date and ensure that all current licenses and labels are readily available.

Minimum Qualification Requirements:

1. Bachelor’s degree or equivalent in a relevant scientific subject.
2. Foundational knowledge and understanding of regulatory environment.
3. Good communication skills and ability to prioritise.
4. Demonstrated good computer/IT skills.
5. Good knowledge of written and spoken English.

Other Information/Additional Preferences:

1. Ability to adapt to difficult and different challenges.
2. Team working skills with special focus on results.
3. Good time management skills.
4. Good capability to establish positive networking both internally and externally (e.g. trade associations).
5. Knowledge of Quality systems.

EMBRACING DIVERSITY:

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 () 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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