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Regulatory Affairs Executive
Andheri (E), Mumbai, India
Duties 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)
Ryvis Pharma is a 100% Export Oriented, Dynamic & Growing Pharmaceutical Company, a part of Canadian MNC, Exporting Pharmaceutical Formulations for last two decades.
If Interested, Please share your Updated CV with following details:
- Current Company:
- Current Designation:
- Current CTC:
- Expected CTC:
- Years of Experience:
- Notice Period:
- Reason for Job Change:
The Operations Associate is responsible for all inventory, order and logistics management activities for Ryvis Pharma Canada.
12-month Contract with opportunity to convert to full time based on performance
Mississauga, Ontario, Canada
Inventory and Order Management
- Maintain accurate inventory and SKUs in management software
- Process customer sales orders and final shipping documents
- Issue purchase orders to suppliers as required
- Prepare month end inventory reporting
- Coordinate with international logistics department to fulfill customer sales orders and track status of shipments
- Liaison with clearing & forwarding agents
- Prepare and label couriers/shipments as required
- Office management
- Warehouse management
- Courier documents / parcels etc.
Requirements and Qualifications:
- Prior expereince in logistics, warehouse management and supply chain
- Proactive, self starter that takes full ownership of work and seeks input as required
- Strong written and oral communication skills
- Excellent teamworking and interpersonal skills, with a demonstrated ability to develop good internal and external working relationships at all levels.
- Strong Analytical & problem solving skills with superior attention to detail
- Accuracy and speed in data entry and clerical duties
- High proficiency in Microsoft Office (Word, Outlook, Powerpoint, Excel)
- Approaches all situations with a growth mindset, willing to learn and establish themselves as an expert in critical areas of the role
- Knowledge of the pharmaceutical industry is considered an asset
- Regular 5 days per week; 7.5 hours per day
What We Offer:
- Competitive wages
- Bonus program
- Dynamic close-knit team environment
- Company Events
- Casual dress
- On-site parking
We thank all applicants, but only those selected for an interview will be contacted.
Ryvis Pharma is an equal opportunity employer. We welcome applications from women, aboriginal people, people with disabilities and members of visible minorities. Accommodations in relation to the job selection process are available upon request.