Global Regulatory Affairs Specialist – Product Lifecycle
3 weeks ago
We are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be located from our office locations in Mumbai and Hyderabad Duties will include: CMC Documentation Support - Compile, review, and maintain Chemistry, Manufacturing, and Controls (CMC) documentation - Coordinate with Quality, Manufacturing, and regulatory teams to ensure accuracy and completeness Labelling Activities - Review and update product labelling in accordance with regulatory and internal requirements - Ensure alignment between approved labelling and market implementation Regulatory Operations & Lifecycle Management - Support preparation, review, and submission of regulatory filings - Ensure compliance with CHC regulatory standards, policies, and timelines - Contribute to lifecycle activities including variations, renewals, and maintenance submissions Person Specification - Experienced in Regulatory Affairs, ideally with exposure to CMC, labelling, or lifecycle management - Detail-oriented, organized, and comfortable coordinating across multiple functions - Able to manage priorities in a fast-moving, global environment - Strong communicator with a compliance-focused mindset Why join G&L? This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants. If you're passionate about regulatory excellence and digital transformation in life sciences, we'd love to hear from you.
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Regulatory Affairs Specialist
3 weeks ago
India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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Regulatory Affairs Specialist
1 week 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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▷ [Urgent] Regulatory Affairs Specialist
3 weeks ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
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[3 Days Left] Regulatory Affairs Specialist
3 weeks ago
India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Analyst
6 days ago
India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...
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Regulatory Affairs Specialist –
3 weeks ago
India vueverse. Full timeKey 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...
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Regulatory Affairs Associate
2 weeks ago
India Cisbio Full time**Responsibilities**: Location India - Remote, IN Job ID JR-031455 PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Specialist will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will support regulatory submissions...
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Regulatory Affairs Specialist –
3 weeks ago
India vueverse. Full timeKey Responsibilities:Regulatory Submissions & ComplianceAuthor, 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...
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Regulatory Affairs Associate Director
2 weeks ago
Hyderabad, India Amgen Full timeJob Description About Amgen Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the...
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India Ixoreal Biomed Full timeShri 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, Herbal Extracts,...
