2 Opening(s)
6.0 Year(s) To 7.0 Year(s)
Not Disclosed by Recruiter
Job Summary
The Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all regulatory activities are aligned ...
3 Opening(s)
1.0 Year(s) To 2.0 Year(s)
2.50 LPA TO 3.00 LPA
Job Title: R&D Executive – Dossier / Regulatory Affairs
No. of Positions: 3Company: Concept PharmaLocation: AurangabadCTC: ₹NegotiableExperience: 1–2 YearsQualification: B.Pharm / M.Pharm
Job Summary
Concept Pharma is seeking R&D Executives (Dossier / Regulatory Affairs) to support preparation, compilation, and submission of regulatory dossiers for pharmaceutical products. The role is suitable for freshers as well as candidates with up to 1–2 years ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
15.00 LPA TO 20.00 LPA
Position: Dy. Manager/Manager - RA
Location: Bhimpore - Daman
Experience: 10 - 15 Years
Industries: Pharma
Responsibilities:
Develop and implement global regulatory strategies to ensure product approvals and Market access across multiple regions (FDA, EMA, MHRA, TGA, and Health Canada).
CMC expert in handling the Initial Submissions ...
1 Opening(s)
5.0 Year(s) To 7.0 Year(s)
10.00 LPA TO 13.00 LPA
POSITION TITLE: Senior QA/RA SpecialistJOB LOCATION: Bangalore,IndiaDEPARTMENT: Quality & RegulatoryREQUIRED EDUCATION: Bachelor’s degree in biomedical engineering discipline or equivalent
engineering degreeKEY RESPONSIBILITIES: ➢ Product QA/RA:
• Provide quality and regulatory affairs input to the productdevelopment team and handle all QA & RA responsibilitiesthroughout product development, design change and post marketsurveillance process• As ...
1 Opening(s)
5.0 Year(s) To 6.0 Year(s)
6.00 LPA TO 7.00 LPA
Position: RA Executive (Khopoli)
Location: Khopoli - Raigarh
Experience: 5 - 6 Years
Industries: Pharma
Responsibilities:
Dossier Preparation & Submission
Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets.
Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...
1 Opening(s)
1.0 Year(s) To 2.0 Year(s)
8.00 LPA TO 10.00 LPA
Key Responsibilities: Regulatory Returns Filing: Ensure timely and accurate filing of applicable regulatory returns. Regulatory Inspections: Maintain organized and up-to-date documentation to facilitate seamless inspections. Minimize observations during regulatory inspections through proactive management. Adhoc Requirements Submission: Ensure submission of adhoc requirements within specified time frames. Develop standardized processes for quickly ...
1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
3.00 LPA TO 4.00 LPA
Duties and Responsibilities :
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Timely compile materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...
1 Opening(s)
15.0 Year(s) To 20.0 Year(s)
40.00 LPA TO 40.00 LPA
Principal Accountability/ Key ResultGeneration & Revenue
- Ensure system availability through effective preventive, breakdown, and predictive maintenance of HV/EHV assets.- Track KPIs, grid conditions, and asset health to minimize downtime and improve MTBF/MTTR.- Drive condition monitoring (thermal, oil, relay, PD/IR) and use diagnostic tools.- Lead RCA, PFMEA, and corrective actions to prevent repeat issues and ...
1 Opening(s)
2.0 Year(s) To 8.0 Year(s)
Not Disclosed by Recruiter
Quality Assurance
Administration, training, and auditing of Quality System Tools (Customer Complaints, CAPA, Training, Control Documents, Standards).
Ensure compliance of quality procedures and work instructions with applicable standards.
Conduct audits, training, preventive and corrective actions to maintain the QA system.
Maintain training, qualification, and certification records of personnel.
Approve/disapprove suppliers, vendors, facilities, equipment, processes, and ...
1 Opening(s)
4.0 Year(s) To 8.0 Year(s)
Not Disclosed by Recruiter
Position: RA & QA Associate Location: DelhiWorking Days: 5 Days | Monday - Friday | Timings: 9:00 AM – 5:00 PM
Role Overview
Responsible for regulatory submissions, product registrations, license renewals, and compliance for medical devices in India and neighboring countries. Supports Quality Management System (QMS), audits, CAPA, supplier/distributor quality, and ensures compliant labeling, documentation, ...