Biocon Limited Recruitment 2021.Biocon Limited Notification full detailes below.Biocon Biologics India Limited operates as a biopharmaceutical company. The Company offers treatment for chronic diseases such as diabetes, oncology, cancer, and autoimmune diseases. Biocon Biologics India serves customers worldwide
Important Vacancy details:
- Post Name: Executive – National Regulatory Affairs
- Education:Any Postgraduate in Any Specialization
- Experience:0-3 years
- Location: India-Bengaluru
- Address: BIOCON LTD,HOSUR ROAD,20TH KM,ELECTRONIC CITY,BANG, ALORE, , BANGALORE, Karnataka, India
- Salary: 2,00,000 – 3,00,000 P.A.
- Openings: NA
Job Description: Hiring For Executive – National Regulatory Affairs in Biocon Limited!
Roles and Responsibilities
- Practical knowledge of submissions to CDSCO, SLA, RCGM and other agencies in line with current Indian rules and international guidelines (ICH/WHO/PDA).
- Expertise in the CMC requirement from drug development process, marketing and till post approval activities (product lifecycle management) including CMO site addition on LL basis.
- Prior experience in handling of development of Biologics/ biosimilars and lyophilisation products expertise is highly desirable.
- Knowledge in preclinical and clinical studies (protocol review etc) including Pharmacodynamics studies, toxicology studies, Pharmacokinetic studies.
- Ability to work on complex projects and within cross-functional teams and solution-oriented approach to problem solving.
- Good people management skills, good communications skills (Both verbal & written), understand sense of urgency, be self-starter, go & getter.
- Experience in review of artwork (Label, Carton and PI) for India market as per the current D& C Rules.
- Archiving the data for to keep the tracking system in place w.r.t to ongoing research and development and regulatory status of a product in companys data records.
- Updating the team about all the latest gazette notifications, acts and amendments to Indian Drugs and Cosmetics Act,
- To update and prepare SOP (standard operating procedures) for the department (National Regulatory).
- Other additional responsibilities as assigned.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online
