Regulatory Affairs Operational Support - Colombia
Freyr SolutionsPosted 19 hours ago
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About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, innovative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries. At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration. Regulatory Affairs Operational Support Location: Bogota, Remote Job Type: Indefinite-term contract Position Overview: 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 Experience with TMF and QC Mandatory 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 Fluency in English (written, verbal, reading). What We Offer: Competitive salary and benefits package. Flexible work environment (remote or hybrid options available). Opportunity to work with a global team and contribute to impactful projects. Continuous professional growth through training and development programs. Inclusive, collaborative, and innovative work culture. Why Join Freyr: Be part of a global, fast-growing organization that operates in over 150 countries. Opportunity to work on impactful projects in a dynamic and innovative environment. Competitive salary and benefits package, including performance-based incentives. Flexible work options to support work-life balance. Continuous learning and professional development opportunities. Collaborative and inclusive work culture that values diversity.