Assistant Manager/Sr..Regulatory Affairs Officer- Pharma

Company OverviewRenown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and WHO-GMP,...

Company Overview Renown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and...

Vega Biotec Pvt Ltd forms part of Vega group companies involved in manufacturing and exporting of finished pharmaceutical products and having global presence in 20+ countries. We have an opening for the following post. 1. Regulatory Affairs Executive - Qualification - Bsc. Chem/B.pharma/M.pharm Experience - 1 year minimum Job profile: 1. To assist manager...

Vega Biotec Pvt Ltd forms part of Vega group companies having state of the art manufacturing company in Vadodara and having presence in over 20 countries. Our export arm has an opening for the following post.1. Senior Regulatory affairs executive-Qualification- Bsc/Msc Chem,B.pharma/M.pharmaExperience- Minimum 4 years in RAJob Profile-1. CTD or ACTD dossier...

Position : Exe / Sr. Exe (Regulatory Affairs, Baroda) Grade – G12A/G11B Education – B.Pharm / M. Pharm Experience – 4 to 6 years Location – R&D - Baroda Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various...

Position : Exe / Sr. Exe (Regulatory Affairs, Baroda) Grade – G12A/G11B Education – B.Pharm / M. Pharm Experience – 4 to 6 years Location – R&D - Baroda Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for...

**Role & responsibilities** - EU Dossier preparation and submission to Europe market. - EU ASMF and CEP preparation and submission to Europe with post-approval activities - Handling of EDQM Agency Queries. - Brazilian DMF Preparation and Deficiency response. - China DMF Preparation and Deficiency response. - eCTD publishing in EDUCE software with PDF...

Vega Biotec Pvt Ltd forms part of Vega group companies involved in manufacturing and exporting of finished pharmaceutical products and having global presence in 20+ countries. We have an opening for the following post. 1. Regulatory Affairs Executive - Qualification - B.pharma/M.pharm Experience - 2 -5 years minimum Job profile: 1. Dossier compilation for...

From 2 to 3 year(s) of experience - ₹ 2,00,000 - 3,00,000 P.A. - Vadodara**Roles and Responsibilities** Job Opening for RA Officer having 2 to 3 Years of experience in any Pharma API Manufacturing Company near Vadodara. - To prepare and review of dossier in supervision of RA Head. - Collection, review and compilation of various QA and other department...

Vega Biotec Pvt.Ltd forms part of Vega group of companies having state of the art manufacturing pharmaceutical formulation factories and having global presence in 20+ countries. We have an opening in the export division. 1. QA/RA executive - Experience - Minimum 2 years in pharmaceutical formulation factory Qualification - B. Pharma/ M. Pharma Job...

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...

Job Role :Responsibilities :Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global actionEnsure assessment of 483s, warning letter issued to other organization by USFDA to derive the global actionEnsure assessment of internal learning (such as Quality alert) to derive the global actionPreparation of Global...

Job Role :Responsibilities :Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global actionEnsure assessment of 483s, warning letter issued to other organization by USFDA to derive the global actionEnsure assessment of internal learning (such as Quality alert) to derive the global actionPreparation of Global...

Job Role : Responsibilities : Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action Ensure assessment of internal learning (such as Quality alert) to derive the global action Preparation of...

Job Role :Responsibilities :Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global actionEnsure assessment of 483s, warning letter issued to other organization by USFDA to derive the global actionEnsure assessment of internal learning (such as Quality alert) to derive the global actionPreparation of Global...

Executive and Sr. Executive Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – China , Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. ...

Executive and Sr. Executive Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – China , Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various...

Job DescriptionPOSITION SUMMARYDirect the Global Quality Specialized Training program, ensuring a new portfolio of training offerings are offered to the Sun Global network. (i.e. Investigator Qualifications, APQR/CPV, statistical product evaluation, 6S inspection readiness, QP forums, etc.).The incumbent will assure individual compliance with all applicable...

Job DescriptionPOSITION SUMMARYDirect the Global Quality Specialized Training program, ensuring a new portfolio of training offerings are offered to the Sun Global network. (i.e. Investigator Qualifications, APQR/CPV, statistical product evaluation, 6S inspection readiness, QP forums, etc.).The incumbent will assure individual compliance with all applicable...

Job Description Job Title: Program Manager (Biologics and Biosimilars) Purpose: Primarily responsible to drive the biologics and biosimilars product development. This includes establishing the bridge between management and various cross functional teams such as R&D, Regulatory, Manufacturing, Quality, Clinical, Business Development and Commercial. Driving...