Senior Regulatory Affairs Specialist CIS

Job description

Job Description Join a dynamic Regulatory Affairs team working with CIS countries, where you will play a key role in bringing innovative medicines to patients and ensuring compliance throughout the product lifecycle. This position offers the opportunity to work on product registrations, regulatory strategy, labeling, and compliance activities while collaborating with cross-functional teams and health authorities. Key Responsibilities Prepare, submit, and manage marketing authorization applications and regulatory submissions for assigned products. Support product lifecycle management, including variations, renewals, labeling updates, and other post-approval activities. Coordinate responses to regulatory authority questions and support product approvals and launches. Prepare, review, and maintain local labeling documentation and packaging materials in compliance with regulatory requirements. Manage artwork implementation and ensure alignment with approved product information. Maintain regulatory records, databases, and tracking systems to ensure accurate and audit-ready documentation. Monitor regulatory changes and assess their impact on products and business activities. Provide regulatory guidance and support implementation of new regulatory requirements and procedures. Qualifications & Experience Master’s degree in pharmacy, Life Sciences, or a related scientific discipline. Minimum 4 years of experience in Regulatory Affairs, product registration, or pharmaceutical regulatory compliance. Strong knowledge of local pharmaceutical regulations, registration procedures, and compliance requirements for medicinal products. Proven experience with marketing authorization applications and lifecycle management activities. Experience in labeling management, artwork review, and regulatory documentation. Familiarity with regulatory databases, document management systems, and digital regulatory tools. Experience interacting with health authorities and managing regulatory submissions. Proficiency in English and the local language, both written and spoken. Required Skills: Audits Compliance, Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Product Management, Project Management, Regulatory Affairs Compliance, Regulatory Operations, Regulatory Requirements, Regulatory Submissions 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: 08/13/2026*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.