Officer/Senior Officer Vacancy @ Sanofi
Sanofi is recruiting MTech & MSc candidates for Officer/ Senior Officer vacancy. Interested and eligible candidates, check out all details on the same below:
Job Name: Officer/Senior Officer
Reference ID: R2499207
Employment Type: Full Time
- 3 to 4 years prior experience in Regulatory Affairs related to biologicals/vaccines in India and or International countries.
- Technical writing skills.
- Preparation and review of different documents such as CTD, Clinical Trial Application, Marketing Authorization Application etc.
- Knowledge of biologicals regulatory pathways in India.
- Knowledge/experience in electronic submissions.
- Understanding of GMP, GDP and GLP.
- Computer software knowledge (e.g. MS Word, Excel, Power point etc.)
- Must have strong ability to grasp complex technical information and have problem solving skills, as well as the ability to handle multiple projects simultaneously.
- Prepares regulatory submissions and ensure all the data supplied are of the highest quality possible in terms of both content and presentation whilst meeting agreed deadlines.
- Prepares responses to questions from regulatory agencies, affiliates, distributors and within Sanofi.
- Prepare, review and update summary documents, SOPs, etc. Performs other regulatory duties as required (e.g., document preparation for regulatory inspections).
- Maintains RA databases, core dossiers and summary documents.
- Working proactively with members of the Global Business Units and with other functions to ensure business needs are met compliantly within agreed timelines
- To maintain internal training matrix and co-ordinate trainings of regulatory staff as required
Qualification required: B. Pharm / M. Pharm. / M. Sc. / M. Tech.
Areas of Specialization: Pharmacy, Microbiology, Biotechnology, Industrial-Microbiology, Virology, Bacteriology, Life Sciences.
Preferred Experience range From 2.0 to 4.0 Years