Job DescriptionSenior Regulatory Affairs Specialist – Animal HealthLooking for a different challenge as a Senior Regulatory Affairs Specialist whereby you can utilise your skills?Permanent Full-time position with competitive remuneration and benefitsLocation: Sydney, Macquarie ParkHybrid, work from home and office environment, with a dedicated and welcoming teamJoin a growing, yet already successful marketUpskill and growth in an area you're passionate about, whilst being fully supported and encouragedJoin a trusted Global leading Animal Health organisationThe primary responsibility of the Senior Regulatory Affairs Specialist is to drive the development, importation, and registration of new products and to ensure internal and external regulatory compliance for the entire product range.Of critical importance to the successful execution of this role is management of new product development and registration projects and for conducting routine regulatory operations to ensure compliance.The Senior Regulatory Affairs Specialist sits within the Animal Health organisation and reports to the Regulatory Affairs Manager.What You Will DoResponsibilities include, however not limited to:Regulatory Project ManagementRegistration of new products – Review, compile and submit registration dossiers and data packages for agreed key projects, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply.Product stewardship for existing portfolio, including providing regulatory support for additional claims, variations.Provide regulatory support to conduct research trials for new products or label extensions for existing products.Identify and communicate risks to approvals or timelines agreed as part of project planning.Propose options to address any technical / regulatory concerns as applicable.Support the development of the regulatory strategy for new technologies in Australia. This will include liaising with Regulatory authorities in Australia with the view of gaining market access for these new technologies.Regulatory Compliance and Technical SupportProvide regulatory and technical advice as requested to other parts of the organization to ensure that correct and compliant information is used in decision making and strategy development.Support of the Change Control process.Maintain relevant Permits and Licences.Ensure that our company's products comply with the regulatory and legal requirements set by the local regulatory authorities.Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate and our company Animal Health's policies and standards, and reflects our company's Code of Conduct.Participate in PQC investigations and recall actions as required.Maintain all documentation in accordance with Company and relevant quality standards.TrainingComplete all training requirements, in accordance with company and relevant quality standards requirements.Attend relevant training courses as the opportunity presents.Ensure good housekeeping in the work area in accordance with company and relevant quality standards.PharmacovigilanceFollow global and local procedures to ensure suspected adverse events are timely reported and meet the local legislative requirements.Ensure that all PV obligations relating to both internal local/global company processes AND Australian/ NZ regulatory requirements are met.For Specialists with PV back-up responsibility:Maintain a current local and Global PV training status (to National PV team level) - as directed by the local DPOCAssist with entry of local PV cases into PV Works as directed by your manager and in accordance with local and global PV procedures and timelinesWhat You Must haveGraduate or Post-Graduate degree in relevant biological scienceSolid prior experience in regulatory affairsKnowledge of relevant Australian Regulatory SystemsDemonstrated regulatory experience with vaccines and biologicals highly desiredHighly developed skills in negotiating, influencing, leadership with excellent communication and organizational skillsUnderstanding of quality systemsAbility to analyse data. Logical and analytical approach to problem solvingAbility to work well with other departments in a team setting. Self-starter with initiative who works well with minimal supervisionAbility to work under pressure to meet deadlines and to make sound decisions on a day-to-day basis concerning regulatory affairsWhat You Can ExpectWork autonomously whilst being supported, encouraged and being part of a trusted Global leading Animal Health organisationExposure to upskill and develop in your roleFlexibility and opening doors to other opportunities and skillsetsJoining a collaborative team of likeminded individualsWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:12/25/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID:R323456
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