1 Opening(s)
5.0 Year(s) To 6.0 Year(s)
2.40 LPA TO 4.20 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 ...
1 Opening(s)
3.0 Year(s) To 5.0 Year(s)
2.50 LPA TO 3.60 LPA
Regulatory Affairs Officer (RA)
Qualification: B.Pharm/ M.Pharm
Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience.
Job Description:
Preparing dossiers as per country-specific guidelines.
Compiling and reviewing documents.
Coordinating with QA for documentation.
Addressing queries raised by respective countries' FDA.
Bond: 18-month ...
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 ...
1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
4.50 LPA TO 5.00 LPA
Job description for API Regulatory:
Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP.
Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates).
Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 15.00 LPA
Job Description
-Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in preparation of CTD section as per regulatory requirements of different region
-Having experience in preparation of query response and PAS, CBE and annual report.
-Have ability to co-ordinate with ...
2 Opening(s)
3.0 Year(s) To 4.0 Year(s)
6.50 LPA TO 8.00 LPA
Role:
• Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.
• Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.
• Drafting and revising pre-clinical summaries.
• ...