Ryvis Pharma, we strive to make the highest quality products at affordable prices. Since entering the pharmaceutical industry over two decades ago, we have become a torchbearer in globally competitive high-quality FDA approved products.
Company Name: Ryvis Pharma Pvt. Ltd.
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 firstname.lastname@example.org