Ami Life Sciences Hiring Chemistry Graduates for the role of Regulatory Affairs Executive
Job Title: Regulatory Affairs Executive
Location: Vadodara/Baroda, Gujarat
Company: Ami Life Sciences
Minimum Qualification: B.Sc / M.Sc Chemistry, B.Pharma / M.Pharma
Experience: From 2 to 7 year(s) of Experience
Roles and Responsibilities:
- EU Dossier preparation and submission to the European market.
- EU ASMF and CEP preparation and submission to Europe with post-approval activities
- Handling of EDQM Agency Queries.
- Brazilian DMF Preparation and Deficiency response.
- China DMF Preparation and Deficiency response.
- eCTD publishing in EDUCE software with PDF processing of documents.
- Cross-Functional Team leading for project completion.
- Preparation, Review, Submission, and Life Cycle Management of USDMF.
- Preparation, Review, Submission, and Life Cycle Management of ANDA.
- Handling of USFDA Agency Queries.
- Preparation and Review of Product Label and Pack-insert.
- Customer correspondence for regulatory requirements.
- Regulatory documents preparation like Applicants part, Restricted part, technical packages, and technical information to customers.
- Review of Regulatory Documents like TTD, AMV, PDR, Characterization report, Change control etc.
- Markets Handled: USA, Europe, Canada, Brazil, other ROW etc.
Possible Interview Questions and Answers:
- Can you explain your experience with EU Dossier preparation and submission to the European market?
Sample Answer: In my previous role, I was responsible for preparing and submitting EU dossiers for our products to gain regulatory approval in the European market. This involved compiling all the necessary documentation, ensuring compliance with EU regulations, and liaising with regulatory authorities. I also coordinated the submission process to ensure timely approvals.
- What is an ASMF and CEP, and how have you prepared and submitted them for Europe?
Sample Answer: An ASMF (Active Substance Master File) and CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) are critical documents for regulatory approval in Europe. I have prepared and submitted these documents by compiling comprehensive technical data on active substances, ensuring compliance with European Pharmacopoeia requirements, and submitting them to the relevant authorities. I also managed post-approval activities, including updates and amendments as needed.
- How do you handle EDQM Agency Queries, and can you provide an example?
Sample Answer: Handling EDQM Agency Queries involves prompt and accurate responses. I have experience in researching and addressing inquiries from the European Directorate for the Quality of Medicines (EDQM). For example, when we received a query about the manufacturing process, I collaborated with our technical team to provide detailed responses, ensuring transparency and compliance.
- Describe your experience in preparing Brazilian DMFs and responding to deficiency notices.
Sample Answer: I have prepared Brazilian Drug Master Files (DMFs) by compiling comprehensive technical data and submitting them to Brazilian regulatory authorities. When deficiencies were identified, I worked closely with our team to address them promptly. For example, in a recent case, we received a deficiency notice related to stability data. I coordinated with our lab to generate additional stability data and submitted a comprehensive response to meet regulatory requirements.
- Can you share your approach to preparing and responding to China DMFs?
Sample Answer: Preparing China DMFs requires adherence to Chinese regulatory standards. I have experience in compiling and submitting these documents, ensuring they align with the China Food and Drug Administration (CFDA) requirements. When responding to deficiency notices, I coordinated with our Chinese regulatory experts and made necessary amendments to address the issues raised.
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