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 [email protected], 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.
Editors Note: Biological E. looking for RA Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
