Ryvis Pharma Pvt. Ltd Job Openings for Regulatory Affairs Department

Ryvis Pharma Pvt. Ltd Job Openings for Regulatory Affairs Department

Ryvis Pharma Pvt. Ltd Job Openings for Regulatory Affairs Department

Company Name: Ryvis Pharma Pvt. Ltd.

Industry: Pharmaceuticals

Office Location: Andheri (E), Mumbai, India

Roles and Responsibilities:

To prepare and review the dossiers in the format of CTD / ACTD and specific formats as per the respective countries guidelines.

Responding to queries raised by MOH of the above regions in the stipulated time frame.

To be able to coordinate with plants to get the Dossiers/Technical documents and samples of products for registration.

To review the technical the documents for preparing the dossier.

To review the artworks and get approval on the same from the plants.

To check the availability of the documents and able to evaluate the documents at different plants.

To have a good knowledge of CTD & ACTD formats.

Well versed with ICH Guidelines.

To conduct reference study search in libraries / Internet for accumulating comparative technical data of various formulations.

To check the compliance status of the Quality Systems followed at the manufacturing site in line with the submitted dossiers.

To evaluate and comment on the requirements of BE/Clinical studies.

Should be able to prepare raw data for the dossier.

Skills and Qualifications:

B-Pharma/M-Pharma Candidates can apply

Preferably 3-4 years of experience in DRA Department

Experience with ACTD/CTD Dossiers.

Exposure to Drug Regulatory Affairs.

Good Knowledge of ICH guidelines.

Technically Comprehensive.

Fine Analytical Skills and Systematic approach.

Proactive approach to problem-solving.

Good computation Skills.

Strong and consistent.

Logical Interpretation of Data.

Ability of multi-tasking.

Fluent in English (Speaking, writing, reading, and understanding)

Computer Skills (Ms. Excel, Ms. Word, Internet, Email

Kindly share your CV at hrdept@ryvispharma.com