Biological E. looking for RA professionals – B Pharma/M Pharma
Dont forget to check out possible interview questions for this job below
Biological E Limited (also known as BioE) is an Indian biotechnology and biopharmaceutical company based in Hyderabad, Telangana is hiring pharma regulatory associates. B Pharma/M Pharma candidates apply. Pharmacy job. Intrested and eligible candidates may check out all the details on the same below:
Role-1
Department: Regulatory Affairs (Injectable
Affairs (Injectable Formulations)
USA/EU/Canada markets
Designation: Assistant Manager/ Deputy Manager
Qualification: M. Pharmacy /B. Pharmacy, Experience:7- 10 years of
experience
Work Location: Shameerpet – Hyderabad
Job Skills:
• Good regulatory work experience in sterile injectable formulations
(In regulated markets like USA/EU/Canada)
• Combined work experience in regulated and emerging markets is
more desirable ill 37%
• Knowledge on drug-device combination products/complex products
• Knowledge on eCTD tools, Labeling/ SPL preparation
• Good communication and drafting skills
• Ability to work with minimum guidance
Job description:
• Dossier review & compilation for global markets
• Post approval Life cycle management
• Dossier publishing using eCTD tools
• Product development support like CC, meeting package, strategy
preparation
• Review of master documents for submission Coordination with CFT for regulatory requirements
Role -2
Department: Regulatory Affairs (Injectable Formulations) – Emerging
markets
• Knowledge on Labeling preparation
• Good communication and drafting skills
• Ability to work with minimum guidance
Job description:
Designation: Assistant Manager/ Deputy Manager
Qualification: M. Pharmacy /B. Pharmacy, Experience: 10 -12 years of
experience
Work Location: Shameerpet – Hyderabad
Job Skills:
• Good regulatory work experience in sterile injectable formulations in global markets
• Combined work experience in regulated and emerging markets is more desirable
• Dossier review & compilation for global markets
• Post approval Life cycle management
• Review of master documents for submission
• Coordination with CFT for regulatory requirements
How To Apply:
Interested candidates please share your Profile on or before 7th April 23
to kishore.dodda@biologicale.com, please mention mail subject as “RA
-712”
View Main Notification
Important Interview Questions and Answers for the above job role:
- What kind of regulatory work experience do you have in sterile injectable formulations, particularly in regulated markets like USA/EU/Canada?
Answer: I have worked on dossier review and compilation for global markets, post-approval life cycle management, product development support, and review of master documents for submission. I have experience working with drug-device combination products/complex products, eCTD tools, and labeling/SPL preparation.
2. Have you worked in both regulated and emerging markets? How has that experience been?
Answer: Yes, I have worked in both regulated and emerging markets. My combined work experience in regulated and emerging markets is more desirable, and I have found that it has given me a broader understanding of regulatory requirements and challenges. It has also helped me adapt to different regulatory frameworks and market environments.
3. What are the key skills required for a pharma regulatory associate position?
Answer: Good regulatory work experience in sterile injectable formulations, knowledge of eCTD tools, labeling/SPL preparation, and drug-device combination products/complex products. Good communication and drafting skills, ability to work with minimum guidance, and coordination with cross-functional teams for regulatory requirements are also important skills.
4. What is your experience with dossier publishing using eCTD tools?
Answer: I have experience in compiling and publishing dossiers for global markets using eCTD tools. I have also worked on updating dossiers during post-approval life cycle management.
5. How do you keep yourself updated on changes in regulatory requirements?
Answer: I keep myself updated through various sources like regulatory agencies’ websites, publications, conferences, and workshops. I also network with colleagues in the regulatory affairs field and participate in training programs to stay up-to-date with the latest regulatory developments.
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