Otsuka Pharma Job Openings – BPharma & Mharma Walk-In
Otsuka Pharma Job Openings – BPharma & Mharma Walk-In. Interested and eligible applicants can check out all of the details on the same below:
Job position: Process Incharge / Sr. Process Incharge – Regulatory Affairs
Job Location: Ahmedabad (Corporate Office)
Qualification: B.Pharm, M.Pharm
Experience: 02-05 years
Email ID: [email protected]
Roles and Responsibilities:
- Dossier preparation/review as per country-specific guideline/CTD guideline
- Timely query response submission to Distributor/ MOH
- Review of documents for their correctness and compliance with respective regulatory guidelines (as per country requirement)
- Preparation, review, and release of artwork and sales orders as per country approval
- Variation documents preparation and filing as per country requirements
- Timely dispatch of tender documents to country/parties as per deadline
Desired Profile:
- Regulatory Affairs experience is mandatory.
- Should be able to review and interpret the country-specific requirements
- Should be able to review various plant documents for dossier preparation like Process Validation, Stability Study, PDR, Method Validation, SOP, Drug Master file, BMR, APR, etc.
- Should be able to communicate with relevant functions for procurement of required regulatory documents
- Should be able to communicate with relevant counterparts in the countries
- Immediate joiners preferred
Interview Details:
- September 23, 2023 at 9:00 AM – 02:00 PM
- Otsuka Pharmaceutical India Pvt. Ltd. 21st Floor, B Block, Westgate, near YMCA Club, S.G. Highway, Ahmedabad-380015, Gujarat
Note on how to apply:
- Simply walk into the interview venue at the specified date and time provided if
you have prior experience in Regulatory Affairs - Bring a copy of your updated resume and any relevant documents
Possible interview questions may be asked for Sr. Process Incharge
1. Can you explain your experience in preparing and reviewing dossiers in accordance with country-specific guidelines or CTD (Common Technical Document) guidelines?
Answer: “I have extensive experience in preparing and reviewing dossiers for regulatory submissions. This includes compiling all required documentation in alignment with country-specific regulatory requirements and CTD guidelines to ensure successful submissions.”
2. How do you handle the timely submission of query responses to Distributors or Ministries of Health (MOH)?
Answer: “Timely query response submission is crucial in regulatory affairs. I prioritize efficient communication and coordination to ensure that queries are addressed promptly and that responses are submitted within the specified timelines.”
3. Can you share your approach to reviewing documents for correctness and compliance with regulatory guidelines?
Answer: “When reviewing documents, I meticulously check for correctness and adherence to regulatory guidelines. I compare the content against the specific requirements of the country in question, ensuring that all necessary information is included and accurate.”
4. Could you describe your experience with the preparation, review, and release of artwork and sales orders in accordance with country approvals?
Answer: “I have been responsible for overseeing the preparation, review, and release of artwork and sales orders, ensuring they align with the approvals obtained for each country. This process involves meticulous attention to detail and adherence to regulatory specifications.”
5. Have you been involved in preparing and filing variation documents as per country-specific requirements? Can you provide an example of such a scenario?
Answer: “Yes, I have experience in preparing and filing variation documents as per country-specific requirements. For instance, in a previous role, I successfully prepared and submitted variation documents to address changes in product formulations, packaging, or labeling, ensuring compliance with regulatory guidelines.”
