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 analysis ...

A Regulatory Affairs Associate supports the development and execution of regulatory strategies to ensure products meet all necessary legal and safety requirements. They prepare and manage regulatory documentation, i...

Role & responsibilities Review of post approval changes and evaluating its impact on the products.Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports.Management of product ...

Role & responsibilities Should have In-depth knowledge of the US ANDA (Abbreviated New Drug Application) requirements, with expertise in the entire process from submission to approval. This includes familiarity with...

Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reportsRequired Candidate profileGood relevant exp...

Roles & Responsibilities:Develop and execute regulatory strategies for the registration and lifecycle management of pharmaceutical products in ROW markets.Compile, review, and submit high-quality regulatory dossiers (CT...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, en...

As a part of our dynamic team, you ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhanc...

Prepare, review, file, and support premarket documents for global registrations for assigned projects..Review pre-clinical, and clinical protocols and associated reports to be used.Collaborate with business unit and internati...

Planning, organizing and implementing strategies and activities required to procure regulatory approval for new and revised product lines under the guidance of more senior regulatory professionals. Ensuring compliance to all ...

Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have...

Proficient in preparing & submitting regulatory fillings for product approvals, conducting clinical evaluations, managing risk assessments, ensuring post market compliance. Experienced in EU MDR 2017/745, US FDA, Indian M...

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...

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...