Regulatory Affairs Executive-API Pharma
1 day ago
Role & responsibilities
1.Ensure proper documentation and fulfillment of statutory requirements with regards to various
FDA authorities.
- Collect information from various departments and prepare DMFs, Dossiers, amendments
and supplements etc
- Submit them to the pertinent regulatory authorities within a specified time frame to get
approval.
- Respond to queries as they arise and ensue that regishation/approvals are $anted without
delay.
Coordinate customer and reeulatorv audits.
Provide compliance to customer complaints by coordination with marketing department.
Keep up to date of national and intemational legislations, guidelines (available on websites)
and customer practices and concemed departments about the same.
Keep up to date with a company's product range.
Ensure that a company's products comply with the current regulations.
Formulate strategy for all regulatory submissions.
Participate in regulatory and customer inspections, review audit reports and submit
compliance report to regulatory agency.
Maintain approved applications in compliance with appropriate guidance
Identifling the tlpe of changes & submit them as per country guidelines (life cycle
management).
- Monitor progress of all registration submissions country-wise and product-wise.
-
Mumbai, India Double HR Consultancy Full timeMumbai VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience...
-
Regulatory Affairs Executive/ Veterinary Pharma
2 weeks ago
Mumbai, India Double HR Consultancy Full timeMumbai, Vile Parle VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years...
-
Office Regulatory Affairs
2 weeks ago
Mumbai, India Kremoint Pharma Full timeJob Title / DesignationOffice Regulatory Affairs Organization NameKremoint Pharma Pvt. Ltd. Job LocationVikhroli Job Description / Responsibilities Prepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market. Apply for Free Sale Certificate (FSC) and Product Permission...
-
Office Regulatory Affairs
1 day ago
Mumbai, Maharashtra, India Kremoint Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...
-
Mumbai, India Double HR Consultancy Full timeMumbai VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience...
-
Regulatory Affairs Executive
7 days ago
Vashi, Navi Mumbai, Maharashtra, India REMEDY PHARMA Full time**Job Title**: Regulatory Affairs Executive **Experience**: 1 to 2 Years **Job Type**: Full-time **Pay**: ₹1,80,000 - ₹2,20,000 per year **Key Responsibilities**: - Preparation of CTD, ACTD, and country-specific dossiers - Coordinate with the factory for documentation, data collection, and resolving queries - Provide solutions for technical and...
-
Mumbai, India Pharma Placements Full timeJOB DESCRIPTION Regulatory Affairs (Domestic) The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will ensure timely and robust functional/cross functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory...
-
Mumbai, Maharashtra, India Pharma Placements Full time ₹ 8,00,000 - ₹ 12,00,000 per yearJOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will ensure timely and robust functional/cross functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory...
-
Regulatory Affairs Executive
2 days ago
Mumbai, India Amico Formulations LLP Full time**Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...
-
Post Vacant for Regulatory Affairs Executive for
2 weeks ago
Mumbai, India T A Solution Full timePost Vacant for Regulatory Affairs Executive for Mumbai location in Pharma company Posted on -April 3, 2021 Designation -Regulatory Affairs Executive for Pharmaceutical Products Working location - Mulund, Mumbai Gender preference - Male/ Female Qualification - B.Sc., M.Sc., B.Pharm, M.Pharma Target Industry - Pharma Industry Experience Range - 1+...
