Regulatory Affairs Associate - Hampshire, United Kingdom - Proclinical Staffing

Description

The candidate must have UK level submission experience.

The purpose of the Regulatory Affairs Associate/Senior Associate role is to 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 requirementsFoster 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

Primary Responsibilities:
Regulatory Plan ExecutionImplement 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 authorisationsVoicing affiliate perspective and needs to global and regional regulatory contactsEnsuring timely responses to requests from support groups and/or regulatory authoritiesMaintaining marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports)

Maintain regulatory tools in alignment with defined compliance metricsSupport 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.

Communicate changes to appropriate management and cross-functional experts as appropriate and implement locallyFacilitate interactions with regulatory bodies on a regular basisSupport 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), 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 timeframesFollow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labellingRegulatory ComplianceEnsure that internal regulatory IT tools and trackers are up to date and accurateEnsure that all products comply with local regulations and quality system requirements whichever is more stringentEnsure 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 inspections in collaboration with Medicines Quality Organisation and local Ethics and ComplianceImplement corrective/preventative actions as appropriateRaise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functionsSupport implementation of local quality system in line with the global quality system and local regulationsProcess ImprovementEnsure alignment and implementation of internal regulatory initiativesActively participate in affiliate cross-functional teams and provide regulatory input and knowledgeSupport implementation of launch readiness initiativesBuild 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 expertiseMinimum Qualification Requirements:
Bachelor's degree or equivalent in a relevant scientific subjectAt least one year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needsTeam working skills with special focus on resultsAbility to adapt to challenging situationsDemonstrated good computer/IT skillsGood knowledge of written and spoken EnglishOther Information/

Additional Preferences:
Analytical, problem solving and negotiation skillsGood communication skillsProject management skillsStrong planning and priority settingGood capability to establish positive networking both internally and externally (e.g. trade associations)Knowledge of Quality systemsProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.