
Regulatory Affairs
21 hours ago
**Department**: Regulatory Affairs
**Designation**: Executive
**Education / Qualification**: B. Pharm
**Experience**: 3 to 5 year
**Salary**: As per company Standards
**Responsibilities**:
- Data compilation, Preparation of DCP, EDMF, CEP, and Drug Master File (DMF)/Formulation Dossier related to other countries as per marketing department requirement and handling lifecycle Management.
- Preparation of Insert as per requirement.
- Preparation of DMF Amendment, Revision report, Annual update report of the Drug master file with Regulatory Agencies [Europe, EDQM, Korea and ROW] for the regularization of Changes.
- Making responses to Health Authorities [EDQM, DCP (RMS & CMS)] and Customer queries.
- Drafting Letter of access to existing Drug Master Files and declarations/notifications for regulatory submissions and customers & Marketing department.
- Review of Analytical method validation, Process Validation, Checking BMR documents for EU DMF filings.
- Drafting and submission of Technical Information packages of New Active Pharmaceutical Ingredients for customers.
- Extracting information required for submissions from various departments (R&D, QC, QA & Production) within the organization.
- Checking of Change controls.
- Necessary communication and assessment of outsourced intermediates/Starting materials of APls.
- Regular updation of Regulatory Guidelines.
- Timely submission of DMFs as per the monthly schedule.
- Involvement of in group discussion of New projects with R&D, Marketing.
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Executive Regulatory Affairs
22 hours ago
Thane, India Bazillion Full time**Executive Regulatory Affairs (API Pharma)** **Qualification**: M.Sc. - Organic & preferably diploma or must have worked in Regulatory Affairs department of Pharmaceutical Organization / API **Experience** : 8 - 10 years in Quality Assurance department (QA) of Pharmaceutical Industry & regulatory Affairs department ,preferably from API Pharma industry. -...
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Regulatory Affairs Executive
22 hours ago
Thane, India Double HR Consultancy Full timeRegulatory Affairs Executive (female)/ Palghar East Thane, Palghar Share VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Palghar East Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of...
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Regulatory Affairs Associate
2 days ago
Kalher, Thane, Maharashtra, India LAPAROMED PVT LTD Full timeAs a regulatory affairs officer, you'll need to: - ensure that a company's products comply with the regulations of the regions where they want to distribute them - keep up to date with national and international legislation, guidelines and customer practices - respond to queries from medical bodies like Healthcare products Regulatory Agency (MHRA) -...
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Regulatory Affairs Officer
1 week ago
Thane, India BAJAJ Healthcare Ltd Full time**Department**: Regulatory Affairs **Designation**: RA - Officer **Education / Qualification** : B. Pharm **Experience**: 0 to 1 year **Salary**: As per company Standards **Responsibilities**: - Registering our manufacturing site in Sedex platform, completing Responsible Sourcing Policy and initiating for Smeta 4 pillar Audit from 3rd party Audit...
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Regulatory Executive
22 hours ago
Thane, India Double HR Consultancy Full timeRegulatory Executive (Female)/ Dombivli - Mumbai Pharmaceutical Thane, Dombivli Share 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...
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Regulatory Affairs Executive
22 hours ago
Thane, India Generic Aadhaar Full timeHandling dossier, COPP submission and query Handling for South East Asian Country, East Africa, Latin America, Central America, Europe. - In depth knowledge about regulatory requirements for above region - Need to work independently - Need to have knowledge about legal documents requirement and it’s processing. - New customer development and new business...
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Regulatory Affairs Officer/executive
1 week ago
Boisar, Thane, Maharashtra, India R5 Consultants Full timeReview and interpret applicable regulations and guidelines - Manage and ensure the accuracy of regulatory documents - Monitor and respond to changes in the regulatory environment - Develop and maintain strong working relationships with relevant stakeholders - Participate in internal and external audits - Keep up to date with developments in the regulatory...
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B.sc & M.sc Fresher
1 week ago
Thane, India Maxima Solutions Full timeJob description Designation title / Role title **Trainee - Regulatory Affairs & Sourcing** Department -Regulatory Affairs Band - Junior level Business Unit - Maxima Solutions Overall Role Purpose - Assisting in regulatory affairs and sourcing for complete organization. Reports to - Executive - Regulatory Affairs & Sourcing Scope of Role Mention Key...
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Regulatory Affairs Executive
2 days ago
Hiranandani Estate, Thane, Maharashtra, India Oviani Pharmachem Pvt Ltd Full timeWe are looking for young and enthusiastic minds, who will be responsible for the following roles - 1. Preparation and compilation of CTD and ACTD dossiers for Vietnam, Myanmar and ROW market 2. Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for...
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Regulatory Affairs Executive
6 days ago
Thane, India Toptime Network private ltd Full time**Documentation: Related all to QA, TM etc** **Logistic: Direct enquiry for product from Consumer/Clients** **Communication: Related to project/sample requirement.** **Others: 1.Updation and checking GS1 data kart.** **2. Fssai/FoSCOS updation/tracking for license/ renewal -** **Salary**: ₹12,000.00 - ₹18,000.00 per month Schedule: - Day...