Regulatory Affairs Specialist
6 days ago
Lead 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, dossier preparation, and Health Authority interactions. Develop and implement robust regulatory strategies for new product registrations, life cycle management, and market expansion plans in alignment with global business goals. Ensure all regulatory documentation is accurately maintained, audit-ready, and aligned with internal SOPs and external audit requirements. Strategically plan, manage, and supervise the preparation, compilation, and timely submission of high-quality regulatory dossiers, ensuring full compliance with country-specific and international regulatory requirements. Minimum 10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry, with demonstrated success in handling regulatory responsibilities for both Emerging and Regulated Markets (e.g., US, EU, ROW, LATAM, Asia-Pacific). Proven expertise in regulatory dossier preparation (CTD/eCTD format), submission strategy, and Health Authority engagement. Strong leadership, decision-making, and cross-functional collaboration skills. Excellent understanding of global regulatory guidelines (ICH, WHO, USFDA, EMA, etc.)
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Regulatory Affairs Specialist
4 weeks ago
Noida, India Gentell Full timeJob Description Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a...
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Quality and Regulatory Affairs Specialist
2 weeks ago
Delhi, NCR, Noida, India Saraca Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per yearWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist with expertise in regulatory compliance for medical devices across the EU, India, and the US.Clinical EvolutionMedical WritingTechnical Documentation
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Regulatory Affairs Specialist
6 days ago
Noida, 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, dossier...
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Regulatory Affairs Specialist
5 days ago
noida, 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, dossier...
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Regulatory Affairs Specialist
6 days ago
Noida, 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, dossier...
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Regulatory Affairs Specialist
6 days ago
Noida, 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, dossier...
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Regulatory Affairs Specialist
6 days ago
Noida, 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,...
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Regulatory Affairs Trainer
2 weeks ago
Noida, Uttar Pradesh, India Technoledge Eduresearch Pvt Ltd Full time**Company Description** Technoledge is an educational institution located in Noida. Our primary objective is to provide support for the development, coordination, implementation, and planning of educational programs. We offer a wide range of services including smart hybrid schools, engineering services, manpower solutions, skill development, e-learning...
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Regulatory Affairs Specialist
6 days ago
Noida, Uttar Pradesh, India, Ghaziabad 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, dossier...
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Drug Regulatory Affairs Executive
2 weeks ago
Noida, Uttar Pradesh, India Florencia Healthcare Full time ₹ 6,00,000 - ₹ 12,00,000 per year1. Drug Regulatory Affairs - Job descriptionPrepare CTD, ACTD Dossiers and file regulatory submissionsPerform assessments of new or revised productsManage complaint documentation (including investigation andclosure)Respond to inquiries from regulatory bodiesShould be technically well versed with requirements for Medicineswith fare knowledge about Food...