This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Description Regulatory Specialist Looking for a different challenge as a Regulatory Specialist whereby you can still utilise your skills? Permanent Full-time position with competitive remuneration and benefits Location: Wellington - Upper Hutt, NZ Hybrid, work from home and office environment, with a dedicated and welcoming team Join a growing, yet already successful market Upskill and growth in an area you're passionate about , whilst being fully supported and encouraged Join a trusted Global leading Animal Health organisation The primary responsibility of the 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. The Regulatory Affairs Senior Specialist sits within the Animal Health organization and reports to Regulatory Manager, NZ Animal Health. What You Will Do Responsibilities include, however not limited to: Registration 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, and manufacturing changes. Provide regulatory support to conduct research trials for new products or label extensions for existing products. Support the development of the regulatory strategy for new technologies across ANZ. This will include liaising with Regulatory authorities with the view of gaining market access for these new technologies. Identify and communicate risks to approvals or timelines agreed as part of project planning. Propose options to address any technical / regulatory concerns as applicable. Provide 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. 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 company Animal Health's policies and standards and reflects our company's Code of Conduct. Participate in PQC investigations and recall actions as required. What You Must have Graduate or post-graduate degree in relevant biological science. Prior solid experience in regulatory affairs. Knowledge of relevant New Zealand Regulatory Systems (ACVM, Biosecurity, EPA) Highly developed skills in negotiating, influencing, leadership with excellent communication and organizational skills. Ability to analyse data. Logical and analytical approach to problem solving. Ability to work well with other departments in a team setting. Self-starter with initiative who works well with minimal supervision. Ability to work under pressure to meet deadlines and to make sound decisions on a day-to-day basis concerning regulatory affairs. Understanding of quality systems. What You Can Expect Work autonomously whilst being supported, encouraged and being part of a trusted Global Leading Animal Health organisation Exposure to upskill and develop in your role Flexibility and opening doors to other opportunities and skillsets Joining a collaborative team of likeminded individuals We 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 HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the 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: R318420 #LI-DNI