Biocon Limited Walk-in interview 2021 for Senior Executive/ Asst. Manager – Regulatory Affairs API At India-Bangalore/Bengaluru.Biocon Limited Notification full detailes below.Interested Candidates Apply Now.
Important Vacancy details:
- Company Name:Biocon Limited
- Post Name: Senior Executive/ Asst. Manager – Regulatory Affairs API
- Qualification: MS/M.Sc(Science) in Chemistry, M.Pharma in Pharmacy
- Minimum Experience:3 to 8 year(s) of Experience
- Location: India-Bangalore/Bengaluru
- Contact Number:NA
- Selection Process: The selection will be on the basis of Interview.
Job Description: We have Hiring For Senior Executive/ Asst. Manager – Regulatory Affairs API in Biocon Limited !
- Compilation and submission of DMFs globally for new small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines. Self-review of the compiled DMF to ensure that it is error-free.
- Compilation and submission of amendment to existing DMFs globally in eCTD format and in-line with ICH and region specific (EU, US, Canada, Brazil etc.) regulatory guidelines. Self-review of the compiled DMF to ensure that it is error-free.
- Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.
- Assessment of change proposals from regulatory perspective.
- MSc Chemistry (any specialisation) or M.Pharm with at least 3 – 8 years of work experience in Regulatory Affairs for APIs
- Adequate knowledge in ICH, and various Regulatory Agencies guidelines
- Should have hands-on experience in eCTD software
- Very good writing skill in English
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
Biocon Limited is an Indian biopharmaceutical company based in Bangalore, India by Kiran Mazumdar-Shaw, the founder. The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe. It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon’s biosimilar products are also sold in both bulk and formulation forms in several emerging markets [provide reference]. In research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon.