Senior Regulatory Compliance Specialist

Job Overview:The Regulatory Compliance Specialist plays a pivotal role in ensuring the organization's products comply with international regulatory guidelines and country-specific requirements. Key responsibilities include preparing, reviewing, and maintaining regulatory documents to guarantee compliance. This involves close coordination with internal teams...

Job SummaryWe are seeking a highly experienced and skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in managing CMC regulatory activities, including USFDA submissions, and ensuring compliance with regulatory requirements.Main Responsibilities:Develop and implement effective strategies for USFDA filings, focusing...

Job Overview:We are seeking a skilled Regulatory Compliance Specialist to support end-to-end submissions for global markets. Required experience includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key ResponsibilitiesVariation Documents and CMC Changes: Prepare Variation documents and/or evaluate post-approval...

Regulatory Affairs Specialist RoleThis position focuses on managing regulatory activities for pharmaceutical products in the United States. Key responsibilities include preparing and reviewing documentation, ensuring compliance with FDA guidelines, and interacting with cross-functional teams.Lead and manage regulatory activities, including ANDA preparation,...

Job Title: Senior Training Compliance SpecialistAbout the Role:We are seeking a seasoned professional to lead our training compliance efforts. As a Senior Training Compliance Specialist, you will be responsible for ensuring site employees receive comprehensive training on various areas including GMP, functional, and SOP.Key Responsibilities:Training...

Risk and Compliance Specialist RoleWe are seeking a skilled Risk and Compliance Specialist to join our team. As a key member, you will play a critical role in ensuring the robustness of our risk and compliance function.This position involves working closely with the Senior Risk Manager to identify and mitigate potential risks. Your responsibilities will...

We are seeking an experienced Regulatory Specialist with strong expertise in the power sector. The candidate will be responsible for handling ARR filings, tariff determination, petitions, and compliance with regulatory frameworks . The ideal professional should have a proven track record of working with Regulatory Commissions/Power Utilities and...

**What You Will Do?**: - Maintain monthly bridge files from GAAP (US, SFRS, IFRS, IndAs) to local accounts for Atlan entities. - Support the local statutory audit request. - Supporting the team to roll forward annual bridge files and financial statements - Preparing information for PBC lists & Support preparation of local regulatory and statistical...

we're currently looking for an Senior Compliance Analyst/ Team Lead/AM/Manager and I think you could be a good fit. We are looking for 5+ years of experience in Compliance - Code of Ethics, I'd like to tell you a little more about this position and learn a few things about you as well. Are you available for a quick call? If so, I'd be happy to set up a...

Job Title: Lead Management ExpertAs a seasoned Lead Management Expert, you will be responsible for ensuring the marketability of our products in regulated countries and specifically in EMEA. This involves taking necessary measures to achieve cost efficiency while meeting regulatory requirements.Key Responsibilities:Develop and manage REACH-like registration...