Regulatory Affairs Specialist
24 hours ago
Company OverviewGamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at to learn more about how we can assist in your career advancement.Job OverviewWe are seeking a dedicated Regulatory Affairs Specialist - Pharma to join our team in Hyderabad. This is a full-time, junior-level position designed for candidates with 1 to 3 years of experience. The chosen candidate will be responsible for a variety of regulatory procedures, ensuring compliance and managing strategic regulatory projects within the pharmaceutical sector.Qualifications and SkillsProficient in FDA regulatory submissions, crucial for the timely approval of products (Mandatory skill).Skilled in risk management processes, necessary to identify, assess, and prioritize regulatory risks (Mandatory skill).Adept at regulatory strategy development to efficiently navigate and comply with complex regulations (Mandatory skill).Solid understanding of EU MDR compliance to ensure product safety and efficacy.Experience with quality management systems, enabling efficient organization and processes for regulatory compliance.Knowledge of ISO 13485 standards for designing and manufacturing medical devices.Competency in labeling and documentation review to ensure accuracy and regulatory compliance.Experience in product lifecycle management to oversee the entire regulatory process from development to post-market.Roles and ResponsibilitiesPreparing and submitting regulatory documents to ensure compliance with regional and international regulatory requirements.Collaborating with cross-functional teams to support regulatory strategies and submissions.Conducting risk assessments and implementing risk mitigation strategies.Maintaining up-to-date knowledge of regulatory legislation, guidelines, and standards.Reviewing and approving labeling, promotional, and support materials.Managing timelines and delivering high-quality regulatory submissions within set deadlines.Providing regulatory input for new product development and design changes.Participating in regulatory inspections and audits as required.
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Regulatory Affairs Specialist
2 days ago
Hyderabad, Telangana, India Morulaa HealthTech Pvt. Ltd. Full timeCompany DescriptionMorulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor...
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Senior Regulatory Affairs Specialist
1 week ago
Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...
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Regulatory Affairs- eCTD Specialist
12 hours ago
Hyderabad, Telangana, India Nooha Asp Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRegulatory Affairs Hiring Profile eCTD SpecialistExperience Level: 3 to 6 YearsLocation: Work from office (Hyderabad)Skills & Qualifications:1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the...
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Regulatory Affairs Specialist
4 days ago
Hyderabad, Telangana, India Naukri Healthcare Jobs Full time ₹ 4,00,000 - ₹ 6,00,000 per yearWe are looking for a skilled Regulatory Affairs Specialist to join our team at Medifodil Smart Pharma Solutions, with 4-7 years of experience in the Pharmaceutical & Life Sciences industry.Roles and ResponsibilityDevelop and implement regulatory strategies to ensure compliance with relevant laws and regulations.Prepare and review regulatory submissions,...
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Regulatory Affairs Specialist
1 week ago
Hyderabad, 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 Specialist
2 days ago
Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 2,50,000 - ₹ 7,50,000 per yearCompany OverviewGamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at to learn more about how we can assist in your career...
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Hyderabad, India Dr. Reddy's Laboratories Full timeJob SummaryWe 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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Hyderabad, India Dr. Reddy's Laboratories Full timeJob SummaryWe 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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Hyderabad, India Dr. Reddy's Laboratories Full timeJob SummaryWe 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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Hyderabad, India Dr. Reddy's Laboratories Full timeJob SummaryWe 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...
