Job Description Regulatory Affairs Specialist Join a trusted global leading Biopharmaceutical organization Permanent Full Time position with comprehensive compensation and benefits Use your artwork and labelling expertise in our Regulatory Team Join a dedicated team where you will be supported in your career Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Role Summary The Opportunity As a Regulatory Affairs Specialist, you will play a pivotal role in supporting the day-to-day operations of the Shared Service Delivery Mode (SSDM) AP Labeling & Artwork. What You Will Do Responsibilities include, however not limited to Perform tasks as assigned, and requested by country's Local Labelling Leads (LLL) and Local Artwork Leads (LAL), to deliver labelling and artwork tasks in accordance with our Company's labelling and artwork SOPs, including but not limited to Evaluation of labelling Activities Preparation of labelling content, solicit internal review & approval as appropriate Creation of artwork to support regulatory submissions and market implementation Education Minimum Requirement A tertiary degree Required Experience And Skills Prior experience in regulatory activities relating to artwork and labelling Experience in Pharma industry experience is preferred Excellent attention to detail Good oral and written communications skills Must be able to work effectively with our customers, stakeholders and sales force What You Can Expect Be part of a trusted global leading Biopharma organisation Exposure to develop in your career with us Comprehensive Total Rewards Package to support employees, covering competitive compensation and great health, career and work life benefits! We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we 'follow the science' and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 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 Remote Shift Valid Driving License Hazardous Material(s) Requisition ID R283734
