Direct message the job poster from Freyr Solutions Global Talent Acquisition Manager | Specializing in Pharma/Bio-Tech/Med and IT | Experienced in lifecycle recruitment across the Americas and… About Freyr Inc Freyr Inc. is a leading global regulatory solutions and services company, supporting Life Sciences organizations in their entire regulatory value chain. With a strong emphasis on innovation, collaboration, and excellence, Freyr provides cutting-edge regulatory strategies and solutions across pharmaceuticals, biotechnology, and healthcare. Why Join Freyr - Be part of a global team driving regulatory excellence and innovation. - Work with a collaborative, dynamic, and diverse team of professionals. - Opportunities for continuous learning, professional growth, and development. Benefits at Freyr: - Flexible remote work options and working hours. - Competitive salary packages based on industry standards. - Comprehensive health benefits and additional perks. - A culture that values work-life balance. Job Description: Senior Regulatory Affairs Specialist Location: Remote Key Responsibilities: Preparation of Module 1 Administrative documents Draft, & circulate to GEM RL for review, the requested documents for Module 1. Review quarterly/annual RIMS reports to ensure information is up to date. Communicate & Co-ordinate with LOCs, GEM RL and other MFTs Support GEM RL with submissions (Renewals, Variations, MAA etc) in Growth & Emerging Markets Support GEM RLs to follow up and track relevant labelling activities Supports GEM RL to gather the information from LOCs when needed, Ex: PBRER reportability (program specific information) and renewal planning etc. Supports GEM RL in ordering, tracking and coordinating for M1 Support documents: Ex- manufacturing licences, certificate of analysis, GMP certificates, declaration letters, CPP, samples etc. HA response coordination. Update Product Responsibility List Other regulatory coordination and operational activities Skills and Expertise Required: At least 2+ years of experience in Regulatory affairs Module 1 Management. Bachelor’s / master’s in pharmacy / Pharma / Medical or other associated scientific discipline Certification or courses in Regulatory Affairs. Well versed with country specific regulations for Growth & Emerging Markets Understands CTD/eCTD/Non CTD structure and contents. Ability to work under deadlines and fast paced work environment. Excellent business collaboration/interpersonal skills Computer literacy required in Microsoft Office Products such as Word, Excel, and Outlook Ability to multitask and prioritize competing agendas Join Freyr and contribute to shaping the future of regulatory excellence! Seniority level Associate Employment type Full-time Job function Science, Strategy/Planning, and Consulting Industries Pharmaceutical Manufacturing, Research Services, and Medical Practices #J-18808-Ljbffr