Senior Regulatory Affairs Specialist
20 hours ago
Acme Generics is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. This role involves ensuring compliance with regulatory guidelines and managing technical data requirements.
Key Responsibilities:- We are looking for an individual who can compile, prepare, and review dossiers in CTD, ACTD formats, and country-specific documents as per regulatory guidelines of countries.
- The successful candidate will be responsible for coordinating with various departments (Production, Quality Assurance, Quality Control, Packaging department, and F & D) for technical data requirements.
- A strong understanding of ICH Guidelines (QSEM) and Common Technical Document (CTD) for the registration of pharmaceuticals for human use is required.
- The ideal candidate will be able to prepare and review SmPC, Package insert, and labeling information.
- An ability to file online applications for dossier submission in the US and EU is essential.
- Handling queries received from clients and MOH is also a critical aspect of this role.
As a Senior Regulatory Affairs Specialist at Acme Generics, you will enjoy a competitive salary of approximately $120,000 annually, depending on experience. In addition to your base salary, you will receive benefits such as health insurance, retirement plans, and paid time off.
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Regulatory Affairs Specialist
2 weeks ago
Vadodara, Gujarat, India Lifelancer Full timeAbout UsLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Job Overview:We are seeking a highly skilled Regulatory Affairs professional to join our team on a full-time basis in Vadodara. The ideal candidate will have a...
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Regulatory Affairs Specialist
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Senior Regulatory Affairs Specialist
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Vadodara, Gujarat, India Lifelancer Full timeCompany OverviewRenown Pharmaceuticals Pvt. Ltd. is a renowned contract manufacturer of soft gelatin capsules with a state-of-the-art facility in India.Job OverviewA competitive full-time position for experienced professionals seeking challenging roles in regulatory affairs. The ideal candidate will have 1-3 years of experience and be passionate about...
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Solar Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Vadodara, Gujarat, India Lifelancer Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Officer to join our team at Renown Pharmaceuticals Pvt. Ltd. in Vadodara, India.This is a full-time position for candidates with 1-3 years of experience, offering a competitive salary and opportunities for growth in a dynamic company.About the CompanyRenown Pharma is a reputable soft gelatin...
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Pharmaceutical Regulatory Affairs Specialist
1 week ago
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Regulatory Affairs Expert
1 month ago
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Regulatory Affairs Specialist
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Regulatory Affairs Expert
3 weeks ago
Vadodara, Gujarat, India Lifelancer Full timeAbout the Role:We are seeking an experienced Regulatory Affairs professional to join our team in a full-time capacity. The ideal candidate will have a strong background in regulatory affairs, specifically within the pharmaceutical industry.Key Responsibilities:Ensure compliance with regulatory requirements for pharmaceutical products in target marketsPrepare...
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Regulatory Affairs Professional
1 week ago
Vadodara, Gujarat, India Lifelancer Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Officer to join our team at Renown Pharmaceuticals Pvt. Ltd. in Vadodara, India.This is a Full-Time position for candidates with 1-3 years of experience, offering a competitive salary range and an opportunity to work with a leading soft gelatin contract manufacturer.
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Regulatory Affairs Manager
3 weeks ago
Vadodara, Gujarat, India SUN PHARMA Full timeCompany OverviewSun Pharma is a leading pharmaceutical company that offers a wide range of products and services.Job DescriptionWe are seeking an experienced Regulatory Affairs Manager to join our team in Baroda. The successful candidate will be responsible for managing the regulatory affairs function, including ensuring compliance with relevant regulations...
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Regulatory Affairs Expert
3 weeks ago
Vadodara, Gujarat, India Lifelancer Full timeAbout the CompanyLifelancer is a leading talent-hiring platform in Life Sciences, Pharma and IT, connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Job OverviewWe are seeking a highly skilled Regulatory Affairs professional to join our team in Vadodara on a full-time basis. The ideal...
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Regulatory Affairs Manager
1 week ago
Vadodara, Gujarat, India SUN PHARMA Full timeJob Summary:We are seeking an experienced Regulatory Affairs Manager to join our team at Sun Pharmaceutical Industries Ltd. in Vadodara, India.This is a challenging role that requires strong knowledge of regulatory submissions and experience in managing teams to ensure compliance with Indian regulations.About the Role:Evaluate regulatory strategies for...
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Regulatory Compliance Specialist
4 weeks ago
Vadodara, Gujarat, India Lifelancer Full timeJob OverviewWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Lifelancer. The ideal candidate will have 1-3 years of experience in similar roles and possess a strong understanding of Medical Device Rules 2017.About the RoleThe successful candidate will be responsible for maintaining QM, SOP, Device and Plant Master Files,...
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Global Regulatory Compliance Specialist
2 weeks ago
Vadodara, Gujarat, India Lifelancer Full timeCompany OverviewRenown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India.The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India.Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and WHO-GMP,...
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Regulatory Compliance Senior Professional
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Senior Quality Assurance Specialist
4 weeks ago
Vadodara, Gujarat, India Renown Pharmaceuticals Pvt. Ltd. Full timeCompany OverviewRenown Pharmaceuticals Pvt. Ltd. is a renowned Soft Gelatin contract manufacturer with a world-class facility in India. With over 10 years of experience, the company serves 25+ countries with 300+ products and 150+ customers.Job DetailsWe are seeking a Senior Quality Assurance Specialist for our team in Vadodara, India. This full-time...
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Vadodara, Gujarat, India Renown Pharmaceuticals Pvt. Ltd. Full timeCompany OverviewRenown Pharmaceuticals Pvt. Ltd. is a leading Soft Gelatin contract manufacturer with a state-of-the-art facility in India. With over a decade of experience, the company serves numerous global customers with a diverse portfolio of products.About the RoleWe are seeking a highly skilled Senior Pharmaceutical Quality Assurance Specialist to join...
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Senior Bioanalytical Operations Specialist
4 weeks ago
Vadodara, Gujarat, India SUN PHARMA Full timeJob SummaryWe are seeking an experienced Senior Bioanalytical Operations Specialist to join our team at Sun Pharma. The successful candidate will be responsible for ensuring the quality and integrity of bioanalytical data and supporting the development and validation of analytical methods.About the RoleThis is a unique opportunity to work with a leading...