You will be responsible for maintaining our Quality Management System (QMS), handling batch release activity and working with the team in preparation of technical files in line with regulatory guidelines.Provident fundJob Cl...

Job Role:Create a conducive policy environment for Altius as an Infra Provider.Ensure strong alignment and consistency of policies across the Central, State and Municipality levels.Maintain strong civic society connect throug...

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance s and defined regulatory strategies. He would even be responsible f...

Key Responsibilities:- Develop and implement global regulatory strategies to ensure product approvals.- Market access across multiple regions (FDA, EMA, MHRA, TGA, and Health Canada). - CMC expert in handling the Initial...

Key Responsibilities:Requirements gathering and regulatory analysisSupport with staffing strategy, screening, and interviewsRequired Expertise:Hands-on experience with ISO 13485 QMS, CDSCO dossiers, and/or FDA/...

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desir...

• 4-7 years experiences for RA role in medical device and or pharmaceutical industry• Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requireme...

Role & responsibilities We are hiring for the role of Executive - Regulatory Affairs department (API Industry )Preferred candidate profile Candidate with 3 to 6 years experience in the Regulatory Affairs (API Industry) ca...

Prepare, review, and file global premarket documents, collaborate with teams, develop regulatory strategies, and ensure compliance with India, US FDA, and EU regulations for medical devices or pharmaceuticals.Job Classificati...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, locate...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, loca...

About Antier SolutionsAntier Solutions is a global leader in blockchain, DeFi, and tokenization, driving regulatory-compliant Web3 innovations. As the industry evolves, ensuringlegal and regulatorycompliance is critical for s...

About Antier SolutionsAntier Solutions is a global leader in blockchain, DeFi, and tokenization, driving regulatory-compliant Web3 innovations. As the industry evolves, ensuringlegal and regulatorycompliance is critical for s...

About Antier SolutionsAntier Solutions is a global leader in blockchain, DeFi, and tokenization, driving regulatory-compliant Web3 innovations. As the industry evolves, ensuringlegal and regulatorycompliance is critical for s...

About Antier SolutionsAntier Solutions is a global leader in blockchain, DeFi, and tokenization, driving regulatory-compliant Web3 innovations. As the industry evolves, ensuringlegal and regulatorycompliance is critical for s...

A Regulatory Affairs Specialist ensures a company complies with all applicable regulations for its products, working with regulatory agencies to obtain approvals and maintain compliance throughout the product lifecycle. They ...

Why join AliveCor ?At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for eve...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration.Dossier compilation as per guidelines.Compilation and review the product dossiers for submission in CTD, ACTD.Gap analysi...

Ensure ComplianceCommunication with Regulatory AgenciesDrug Development SupportSubmitting product registration dossiers, clinical trial documentationCOPP product wise approvalAuditRequired Candidate profileQualification B. Ph...

Role & responsibilities Independent variation submission to UK Artwork/PIQ/Safety Submission to EU/UK Renewal submission to EU/UK Sunset Exemption to EU/UK Independent change control assessment EU CTD dossier understandi...

Educational Qualification:Degree in Mechanical Engineering, Electrical Engineering, Applied Sciences, or a related discipline. Professional Experience:10+ years of experience in Medical Device Regulatory Affairs with expertis...

Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline;10+ years of professional experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Q...

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training SessionsPrepare presentationsDeliver Training SessionsJob ClassificationIndustr...

We need Regulatory Affairs Officer for a Reputed Life Science Company of Ahmedabad.Job ClassificationIndustry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Corporate Aff...

Preparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations a...

Title: Regulatory Affairs-CMC (Junior-Senior level)Location: 100% REMOTEExperience: 4-14 YearsIndustry: Pharmaceuticals / Life SciencesJob OverviewJoin our team as a Regulatory Affairs Specialist with 4-14 years of experience...

Exp.: Min 4 to 5 yearsDesignation: Executive- Regulatory AffairsLocation: MumbaiMust have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ RenewalsOther essential skills: LATAM/ GCC/ MENA/ SEA/A...

1. Extensive experience in the pharmaceutical industry with a strong understanding of drug regulatory requirements and processes.2. Strong project management skills and the ability to lead cross-functional teams.3. Strong att...

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & ...

(2 -4) Years of Work Experience in regulatory.WHO Collaborative countries having knowledge of Regulatory guideline viz ICH, EMEA , PIC.Job ClassificationIndustry: Pharmaceutical & Life SciencesFunctional Area / Department...