Regulatory Affairs - Mumbai

The Regulatory Affairs Manager will oversee all functions of the department including scheduling activities, dossier preparation and review, regulatory submissions and approvals, task management and timeliness, compliance assurance, team leadership and development. · ...

Develop and implement regulatory strategies to ensure compliance with EU regulations. · Collaborate with cross-functional teams to prepare and submit regulatory documents. · Conduct thorough reviews of regulatory submissions to ensure accuracy and completeness. · Build and mainta ...

This is a Regulatory Specialist role in the Global Regulatory Affairs Service Center Team in Mumbai (GRASC – Team). The person will be reporting to the Manager Regulatory Affairs. · Author Safety Data Sheets for multiple geographies across the globe as per applicable hazard commu ...

Candidates should have 5 -13 years of experience in pharmaceutical regulatory affairs . · ...

This is a Regulatory Specialist role in the Global Regulatory Affairs Service Center Team in Mumbai.The GRASC – Team is an integral part of the Diversey regulatory function. · Handle key regulatory activities like compliance workflows, creation of SDS, labels, product registratio ...

We are seeking an experienced Regulatory Affairs Specialist to join our team at Associate Allied Chemicals (India) Pvt. Ltd. · Prepare, review, and maintain regulatory documents such as SDSs · , Assist in compiling dossiers for product registration across various regions · , Liai ...

Regulatory Affairs role involves coordination with internal and external parties for regulatory filing related documentation. · ...

Coordination with internal and external parties for regulatory filing related documentation. · ...

Manage domestic regulatory submissions for pharmaceutical finished formulations in compliance with Indian regulatory requirements Compile review and maintain ACTD/CTD dossiers as per CDSCO and other applicable local regulations Handle online regulatory submissions through Sugam p ...

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission · Preparation of respective CTD sections and submission of final query response to agency · Preparation and submission of documents for national phase to re ...

We have an urgent opening coming up with one of the leading Pharmaceutical organization Mumbai (Kandivali West) for the role of Regulatory Affairs. · Should be well versed with Regulatory Affairs Guidelines of South East Asia Africa Middle East LATAM ROW. · Knowledge of Preparati ...

Concept Pharma is looking for a qualified and experienced Regulatory Affairs professional to manage regulatory submissions and ensure compliance with applicable regulations for pharmaceutical products in domestic and international markets. · ...

This is a Regulatory Specialist role in the Global Regulatory Affairs Service Center Team in Mumbai. · ...

We are looking for a qualified and experienced Regulatory Affairs professional to manage regulatory submissions and ensure compliance with applicable regulations for pharmaceutical products in domestic and international markets. · ...

We are looking for a highly skilled and experienced Regulatory Affairs Officer to join our team at a reputed Pharma Company. · Bachelor's degree in Life Sciences or a related field. · Minimum 5 years of experience in regulatory affairs within the pharma industry. · ...

Research and stay updated on regulatory requirements and guidelines Assist in preparing and submitting regulatory dossiers for new drug applications variations renewals and other regulatory submissions in accordance with regulatory requirements. · ...

Olive PharmaScience Ltd is a leading name in global healthcare innovation delivering high-quality pharmaceutical solutions for over 50 years. · Dossier preparation & submissions · Responses to queries / deficiencies · Product registrations & lifecycle management · ...

We are seeking an experienced Regulatory Affairs professional to manage global regulatory submissions and lifecycle activities across Africa, LATAM, Asia, · and other assigned markets.Review batch manufacturing records. · Serve as Product Lead for assigned products. · ...

· Key Responsibilities: · Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. · Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance. · MOH Query Response: Address a ...

Key Responsibilities: · Prepare and compile dossiers for submission to regulatory authorities (CTD/eCTD formats). · Ensure timely submission and tracking of product registration, variations, renewals, and other regulatory filings. · Coordinate with cross-functional departments (R ...