Regulatory Affairs Specialist –
2 weeks ago
Key Responsibilities: Regulatory Submissions & Compliance Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others. Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5). Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD. Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals). Coordinate responses to health authority queries through cross-functional collaboration and data collation. Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions. Project Planning & Management Manage regulatory submissions for multiple products across multiple countries simultaneously. Utilize project management tools to track project milestones, timelines, and deliverables. Ensure efficient time and resource allocation to meet submission deadlines. Foster seamless communication between central regulatory, regional teams, and client stakeholders. Requirements: 8–10 years of core experience in Regulatory Affairs , handling submissions across regulated and RoW markets . Strong understanding of global dossier formats, submission pathways, and lifecycle management. Excellent cross-functional communication and coordination skills. Proven ability to manage complex multi-country regulatory portfolios.
-
Regulatory Affairs Expert
2 weeks ago
meerut, India beBeeRegulatory Full timeJob Description: We are seeking a skilled Regulatory Affairs Specialist to lead our regulatory submissions and compliance efforts. The ideal candidate will have 8-10 years of experience in handling submissions across regulated and RoW markets, with a strong understanding of global dossier formats, submission pathways, and lifecycle management.The successful...
-
Regulatory Affairs Specialist
3 days ago
Meerut, India Naari Pharma Pvt Ltd. Full timeLead end-to-end regulatory activities for Emerging and Regulated Markets, including submissions, approvals, and post-approval changes. Encompassing pre- and post-approval phases such as initial submissions, query responses, variations, renewals, and ongoing post approval maintenance. The role demands strong expertise in global regulatory requirements,...
-
Regulatory Affairs Manager
3 weeks ago
Meerut, India Whatjobs IN C2 Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
-
Senior Regulatory Compliance Specialist
2 weeks ago
meerut, India beBeeRegulatory Full timeRegulatory Affairs Specialist Position OverviewThe Regulatory Affairs Specialist plays a pivotal role in ensuring the smooth navigation of regulatory processes for our company. This position requires an individual who can author, compile, and submit high-quality regulatory dossiers to global health authorities.Key Responsibilities:Conduct dossier gap...
-
Global Regulatory Compliance Specialist
3 days ago
meerut, India beBeeRegulatory Full timeJob OpportunityThe Senior Regulatory Affairs Associate role requires a professional with expertise in preparing and delivering regulatory submissions from a global and regional perspective. Your contributions will be pivotal in ensuring compliance with regulatory frameworks across various regions.Prepare and review Marketing Authorization Applications &...
-
Chief Regulatory Affairs Officer
2 weeks ago
meerut, India beBeeCompliance Full timeEntity Compliance SpecialistAbout usWe are at the forefront of a hiring revolution that aims to make talent thrive everywhere.We empower businesses to hire, onboard, manage and pay talent in 150+ countries, quickly and compliantly.We have a unified employment platform that makes it easier than ever to seize the global hiring opportunity.We are seeking an...
-
Assistant director – international affairs
4 weeks ago
Meerut, India DBS Global University Full timeAssistant Director – International Affairs Location: DBS Global University, Dehradun (UK) About the Role We are seeking a dynamic and experienced professional to join our university as Assistant Director – International Affairs . The role will play a pivotal part in driving our global engagement strategy, strengthening international collaborations, and...
-
Regulatory Document Specialist
2 weeks ago
meerut, India beBeeRegulatory Full timeJob Title: Regulatory Document SpecialistWe are seeking a skilled professional to create, update, and manage regulatory and clinical documents for medical device projects. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.Create and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable...
-
Regulatory Compliance Specialist
2 weeks ago
meerut, India beBeeRegulatory Full timeRegulatory Compliance SpecialistSphera is a leading global provider of enterprise software and services that enables companies to manage and optimize their environmental, health, safety and sustainability. Our mission is to create a safer, more sustainable and productive world.We are guided by our core values of Customer Centricity, Accountability, Bias to...
-
Compliance Specialist II
2 days ago
meerut, India beBeeRegulatory Full timeAt Sphera, we are committed to creating a safer, more sustainable and productive world.We strive to achieve this vision by enabling companies to manage and optimize their environmental, health, safety and sustainability through our enterprise software and services.Job OverviewThe primary function of this role will be to cost-effectively prepare...
