Junior Regulatory Associate

Job DescriptionWe are looking for a Junior Regulatory Associate to join our expanding team. The successful candidate will:Be responsible for the review and finalization of Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA, and ANDA submissions to ensure effective data presentation as per guidanceBe responsible for effective co-ordination with cross functional teams, site, and global Regulatory Affairs teams for the authoring, review, and finalization of dossiers for the pipeline products to ensure effective data presentation and qualityPrepare quality dossiers for pipeline molecules and supplements to support product launch.Monitor and set timelines for filing MA transfers, variations, license renewals, product amendments/supplements, and other product life cycle management activities including annual reports and safety report filing, etc.Collaborate with both global and other regional regulatory client teams to author quality regulatory submissions for pipeline productsReview Health Authority queries and co-ordinate global strategy for responseProvide adequate support, including responding to deficiency letters, to both global and other regional regulatory client teams for securing timely approval of regulatory submissionsProvide regulatory support to team, participate, and provide regulatory advice in technical review.Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate any risksDrive resolution of issues. Communicate issues, impact, and outcomes to global regulatory management and core team.Keep up to date with international legislation, guidelines, and customer practices in all countries that the client is exporting its products toUndertake and manage regulatory inspectionsBe knowledgeable of current regulations and guidance, interpret and implement for assigned projectsResponsible for ensuring compliance to clients submission standards, policies, and proceduresDesirable Skills and Experience2 - 5 years' experience in a regulated life sciences environmentSignificant hands-on registration experience associated with the development, maintenance, and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of CMC writing and authoring, review and approval of labeling documentsProven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment, and practical management of associated impactsDemonstrate the ability to interpret and apply regional/local regulatory guidance for CMC and safety related filing in the pre-approval and post-approval (maintenance) stagesDemonstrate the ability to develop strong and positive working relationships across multiple cultures and locationsKnowledge of global/regional regulatory guidelines and requirements importantProven strength in logical, analytical, and writing ability essentialApply for this job