Senior Regulatory Affairs Associate – UK, Ireland, Malta in BASINGSTOKE

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Senior Regulatory Affairs Associate – UK, Ireland, Malta in BASINGSTOKE, Apply Lilly careers in BASINGSTOKE Hampshire.

 

Position : Senior Regulatory Affairs Associate – UK, Ireland, Malta

Location : Basingstoke, United Kingdom

Job id: R-30938

 

Job Details

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 35,000 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 people around the world.Senior Regulatory Affairs Associate – UK, Ireland, Malta
BasingstokeAbout 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.We have a new opportunity for a Senior Regulatory Affairs Associate role to manage the operational and technical aspects of regulatory affairs for the UK, Ireland and Malta marketing affiliates. 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 requirementsEnsure execution of clinical trial authorisation activitiesFoster an environment of operational excellence and collaborate with cross functional teams to successfully achieve affiliate regulatory objectivesFacilitate and cultivate relationships with the local regulatory agencies and trade associations
We’re looking for you to nail: Regulatory Plan ExecutionImplement the Regulatory Plan in alignment with affiliate business plans and regulatory requirements.Ensure submission and approval of high quality regulatory applications within planned timeframes.Preparation and support of new applications to obtain marketing authorisationsVoicing affiliate perspective and needs to global and regional regulatory contactsEnsuring timely responses to requests from support groups and/or regulatory authoritiesSupport affiliate launch teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plansRepresent the regulatory affairs function as appropriate in brand teams and New Product Planning discussionsMaintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment.  Ensure submission of high quality clinical trial authorisation applications, amendments and notificationsSupport the implementation of any additional risk minimization measures at the affiliate and ensure appropriate metrics are generatedLabellingPerform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP)Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product InformationRegulatory ComplianceEnsure that internal regulatory IT tools and trackers are up to date and accurateEnsure that all products comply with local regulations and quality system requirementsEnsure that the regulatory archive is complete and up to date and ensure that all current licenses and labels are readily availableSupport internal audits / assessments / self-inspections / external inspectionsProcess ImprovementBuild and maintain relationships with key regulatory officials and trade associationsProvide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiativesPersonal and Professional DevelopmentKnowledge and understanding of local regulations and local, regional and global regulatory proceduresAttend appropriate external symposia, workshops or conferences to develop technical expertise
You’ll come to us with:Bachelor’s degree or equivalent in a relevant scientific subjectIndustry gained experience in Regulatory Affairs and experience of dealing with external regulatory agencies, the health care system and marketing needsTeam player skills and good communication Ability to adapt to challenging situationsDemonstrated good computer/IT skillsStrong written and spoken English
Additional Skills/Preferences:Analytical, problem solving and negotiation skillsProject management skillsStrong planning and priority settingGood capability to establish positive networking both internally and externally (e.g. trade associations)Knowledge of Quality systemsThis is a permanent position which offers hybrid working at the Basingstoke office and home.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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