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.
Job title: Senior Associate – GRA Regional Regulatory, UK Affiliate
Location: Basingstoke, UK
Hybrid working pattern (3/2)
ROLE OVERVIEW:
As the GRA Regional Regulatory Senior Associate you will manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, including:
* Execute the Regulatory Plan/objectives to ensure the success of new product registrations, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements.
* Foster an environment of operational excellence and collaborate with cross functional teams to successfully achieve affiliate regulatory objectives.
* Facilitate and cultivate relationships with the local regulatory agencies and trade associations.
MAIN RESPONSIBILITIES INCLUDE:
Regulatory Plan Execution
* Implement the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
* Ensure submission and approval of high-quality regulatory applications within planned timeframes. Maintain or support maintenance of clear metrics for regulatory deliverables.
* Preparation and support of new applications to obtain marketing authorisations.
* Voicing affiliate perspective and needs to global and regional regulatory contacts.
* Ensuring timely responses to requests from support groups and/or regulatory authorities.
* Maintaining marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports).
Labelling
* Perform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information aligns with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or regulatory authority timeframes.
* 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
* Ensure that internal regulatory IT tools and trackers are up to date and accurate.
* Ensure that all products align with local regulations and quality system requirements whichever is more stringent.
* Ensure that the regulatory archive is complete and up to date and ensure that all current licenses and labels are readily available.
* Support internal audits / assessments / self-inspections / external inspections in collaboration with Medicines Quality Organisation and local Ethics and Compliance.
Process Improvement
* Ensure alignment and implementation of internal regulatory initiatives.
* Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge.
* Support implementation of launch readiness initiatives.
ESSENTIAL REQUIREMENTS:
* Industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs.
* Bachelor’s degree or equivalent in a relevant scientific subject.
* Demonstrated good computer/IT skills.
* Good knowledge of written and spoken English.
* 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.
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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