Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate
Company:

Douglas Pharmaceuticals


Senior Regulatory Affairs Associate

Details of the offer

Douglas is one of New Zealand's greatest pharmaceutical success stories with an ever-expanding footprint into global markets. We are working to develop, trial, manufacture, test, pack and distribute the very best medicines, nutraceuticals and products around the world.At Douglas there are around 800 of us - including top scientists, researchers, manufacturers, regulators and engineers, and together we're on a mission to make high quality, effective and accessible products for people who need it.We're helping people with conditions like depression, cancer, heart failure, severe acne and skin conditions, as well as people who need antibiotics and medicines to support their immune system.Are you ready to be a part of it?The roleWe are looking for a Senior Regulatory Affairs Associate to support our Americas markets.This role will be responsible for providing regulatory advice to our project teams to ensure compliance with the relevant overseas Health Authorities. It involves development and maintenance of pharmaceutical dossiers to obtain registration and variation approvals.The effective delivery of regulatory advice and generation of regulatory documents while ensuring they are compliant is essential in our business. This includes:Researching, preparing technical documents and generating responses to client reviews.Reviewing and approving all source documents to ensure compliance.Assisting with the coordination and generation of documentation in support of Product Renewals, Annual Reports, Regulatory Commitments and post-approval changesWhat you'll bringYou will have an awareness of the regulatory sector and have an understanding of dossiers and regulatory affairs processes.Ideally you will also have:Tertiary Qualification in Science or PharmacyMinimum 5 years experience in the pharmaceutical industry with a minimum of 2 years in a Regulatory EnvironmentAchievement DriveStrong customer focus and coordination skillsPlanning and organising skillsExcellent communication and interpersonal skillsAbility to be an active member of a cross-functional teamProblem solving skillsAttention to detailQuality orientation work standardsYou will also be team oriented curious and flexible. You will need to be enthusiastic, high energy and comfortable working in a fabulous open plan environment.What's in it for you?At Douglas, we are empowered to do our life's best work. We do this by continuing to be dynamic and future-focussed, understanding our priorities and working together as a global organisation. We want to make a real difference in people's lives.We are committed to:Being a driven team where professional, and personal development is not just encouraged, but expected.Having authentic leaders who inspire, support and coach to ensure our people flourish.Next stepsIf you're invited to complete a video interview as the next stage of your application, we'd love you to embrace it. Video interviews allow more people the opportunity to demonstrate their abilities to the hiring manager in a new and innovative way giving you a better chance of securing your ideal role. Relax, be yourself and don't worry, we all feel a bit awkward in front of the camera.If you are keen to be part of a true kiwi success story, apply today!All applicants must undergo pre-employment screening and background checks.


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