1 Opening(s)
5.0 Year(s) To 6.0 Year(s)
5.00 LPA TO 6.00 LPA
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 frequently with other employees and team members to coordinate complex activities, often with competing priorities.
Most regulatory affairs positions ...
2 Opening(s)
3.0 Year(s) To 7.0 Year(s)
4.00 LPA TO 8.00 LPA
Key Responsibilities:
Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations.
Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance.
Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals.
Ensure dossiers and product ...
1 Opening(s)
5.0 Year(s) To 7.0 Year(s)
3.00 LPA TO 5.00 LPA
Job Description:
To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials.
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 ...
1 Opening(s)
2.0 Year(s) To 5.0 Year(s)
2.00 LPA TO 5.00 LPA
Job Profile for QA/RA : 2 -3 Years of Experience
? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...
1 Opening(s)
5.0 Year(s) To 10.0 Year(s)
Not Disclosed by Recruiter
Designation: AM / Manager CS legalExperience: CS or ICSI with 5 yrs experience Job Location: Mumbai, Nariman PointSalary Range: Best in industry Mobile Reimbursement , LTA , Annual Bonus, Pf , Gratuity
Working Days: 5 days a week (Mon to Fri) and (Sat and Sun fixed off)
Work Timings: 10:00 AM – 6:00 PM
Key Responsibilities
Corporate Governance
Ensure timely compliance ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
8.00 LPA TO 10.00 LPA
Position: Dy. Manager/Manager - RA
Location: 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 and Life ...
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)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...