Regulatory Affairs - Mumbai City

We are looking for an Officer - Regulatory Affairs - should have exposure to Semi regulated markets in Finished Formulations. · Dossier Preparation ACTD/CTD/ ECTD Country Specific for ROW market & to ensure error free & timely submissions as per marketing dept. timeline. · ...

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

We are seeking an experienced Regulatory Affairs Executive - API to manage regulatory documentation and submissions for active pharmaceutical ingredients (APIs). The role focuses on ensuring compliance with global regulatory requirements through accurate preparation, review, and ...

We are seeking an experienced Regulatory Affairs Executive – API to manage regulatory documentation and submissions for active pharmaceutical ingredients (APIs). Compile, prepare, and review regulatory documents including DMF, DCP, EDMF, and CEP for API products. · Ensure timely ...

This role is for one of the Weekday's clients. We are seeking an experienced Regulatory Affairs Executive - API to manage regulatory documentation and submissions for active pharmaceutical ingredients (APIs). The role focuses on ensuring compliance with global regulatory requirem ...

Preparation of Dossier in CTD ACTD and country specific format. Resolving queries received from various Ministry of Health. Preparation of Technical master file for Medical Device Finalization of Artwork as per Country specific guidelines. · Co-ordination with vendors for DMF and ...

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 ...

We are looking for an experienced Manager – Regulatory Affairs to handle Regulated Markets (US,EU UK RoW Australia etc.) in the pharmaceutical industry. · The role involves managing product registrations regulatory submissions compliance activities authority interactions and lead ...

Job Title: Senior Manager – Regulatory Affairs (Pharma) · Location: Malad · Experience: 12+ Years · Job Summary: · We are seeking a highly experienced Regulatory Affairs professional with 12+ years of experience in the pharmaceutical industry. The candidate must have strong exper ...

· Job Description: · works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. · They must have excellent organizational, analytical, project management, and communication skills. · They work f ...

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. · ...

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 (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 ...

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 ...

Job summary · We are seeking a skilled Regulatory Affairs professional with strong expertise in Indian regulatory frameworks to support regulatory compliance and ensure timely product approvals. · ResponsibilitiesPrepare and submit registration dossiers for certificates and licen ...

We are looking for a Regulatory Affairs Associate with strong expertise in ISO 13485 regulatory compliance and medical device quality systems to join our growing team. · Maintain and improve QMS as per ISO 13485 standards · Prepare, review, and control SOPs, QSPs, and records · ...

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 ...

Roles & Responsibilities: · 1. Dossier Preparation and Submission: · Compile and review regulatory submissions in ACTD, CTD and formats. · Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. · 2. Review of Plant and R&D Data: · Revi ...

Key Responsibilities · Support implementation, maintenance, and continuous improvement of the ISO 13485 Quality Management System · Prepare, review, and maintain regulatory documentation for medical devices, including technical files and device master records · Assist in regulato ...

Responsibilities: · * Prepare dossiers for regulatory submissions in ECTD format. · * Collaborate with cross-functional teams on dossier compilation and submission strategy. · * Manage regulatory affairs for Row market compliance. · ...