Junior Regulatory Affairs Specialist

Job description

Job Description Role overview: Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hard copy submissions. Regulatory Content Management is responsible for supporting the technical integrity of submission components, ensuring that all elements comply with essential standards necessary for submission readiness. Key Responsibilities of Regulatory Content Management: Document Management: Set up document templates, format and publish documents, conduct quality control, and manage submission references to ensure accuracy and adherence to standards; distribute final documents as required. Submission-Ready Components: Deliver submission-ready components that facilitate an efficient submission publishing assembly process. Collaboration: Collaborate with authors, contributors, and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success. Testing and Implementation of New Tools and Processes: Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness. Development of Administrative Documentation: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines, and training materials to support publishing processes. Continuous Learning and Development: Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences. Education Minimum Requirement: High School Diploma or equivalent (no relative experience) Required Skills and Experience: Interpersonal Skills: Ability to work collaboratively with others and communicate effectively, both verbally and in writing. Technical Proficiency: Knowledge of computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly. Time Management: Strong organizational skills to manage multiple time-sensitive assignments efficiently. Adaptability: Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures. Cultural Sensitivity: Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages. Quality and Compliance Awareness: Demonstrates an understanding of the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables. Problem Solving and Critical Thinking: Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges. What we offer:Exciting work in a great team, global projects, international environment Opportunity to learn and grow professionally within the company globally Hybrid working model, flexible role pattern Competitive salary & incentive pay Pension and health insurance contributions Internal reward system and referral scheme 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card Vodafone, Raiffeisen Bank, Foodora, and discount programmes Ready to take up the challenge? Apply now! Know anybody who might be interested? Refer this job! Required Skills: Adaptability, Adverse Event Report, Audits Compliance, Data Quality Assurance, Problem Solving, Quality Management, Regulatory Applications, Regulatory Compliance, Regulatory Management Preferred Skills: 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: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 08/25/2026*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.