Intas Pharmaceuticals Biological Sciences & Biology Job For BSc, MSc Candidates – Apply Now

Intas Pharmaceuticals Biological Sciences & Biology Job For BSc, MSc Candidates – Apply Now

Intas Pharmaceuticals Biological Sciences & Biology Job For BSc, MSc Candidates – Apply Now. Assistant Manager at Intas Pharmaceuticals. Interested candidates can check the details below and send resumes to the e-mail ID given below.

Job role: Assistant Manager/Manager/Senior Manager

Division: Biopharma

We at Intas Pharmaceuticals (Biopharma Division) are currently hiring for below role:

Assistant Manager/Manager/Senior Manager – Regulatory Affairs with 6+ years of experience.

Job Responsibilities:

1. Ensure preparation, review and submission of CTD sections in compliance with requirements of EMA, USFDA and other global markets.
2. Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies.
3. Registration application preparation including administrative documents and GMP audit support for global markets.
4. Publishing of drug registration applications and lifecycle management submissions.
5. Preparation of gap analysis for the registration in regulated and semi regulated markets.
6. Assist in establishing and tracking effective change control management coming for regulatory review and approval.
7. Actively participate in Regulatory Information management system assessment, and implementation.
8. To review CMC documents for its compliance and adequacy of information for regulated market filing.
9. Review and assessment of change controls and related variation submissions to global markets.

Qualifications Required:

• Bachelors/Masters in the field of Biotechnology/Biological Sciences/Pharmacy/Regulatory Affairs

Interested candidates can share their CVs on [email protected]

Here are some interview questions with answers for the job role of Assistant Manager at Intas Pharmaceuticals:

1: Can you explain the significance of CTD sections and their compliance with regulatory requirements? Answer: CTD (Common Technical Document) is a standardized format for submitting regulatory information to health authorities. It includes various sections that provide comprehensive data on drug quality, safety, and efficacy. Compliance with regulatory requirements, such as those from EMA and USFDA, ensures that the submitted information is organized, consistent, and easily accessible for review. Accurate and compliant CTD submissions expedite the regulatory approval process, leading to faster market entry for our products.

2: How do you ensure effective communication with regulatory agencies during the submission process and when responding to queries? Answer: Effective communication with regulatory agencies is crucial for successful submissions and timely approvals. I prioritize clear and concise documentation that addresses all aspects of the submission or query. Regular follow-ups and status updates are maintained to ensure agencies are informed of our progress. Transparency in providing requested information demonstrates our commitment to cooperation and facilitates a smoother review process, ultimately leading to quicker approvals.

3: Describe a situation where you had to handle a complex gap analysis for a regulated market. How did you approach it? Answer: In a previous role, I was tasked with conducting a gap analysis for a regulated market submission. I began by thoroughly understanding the target market’s regulations and our current dossier. I identified gaps in data, documentation, or compliance. Then, I collaborated with cross-functional teams to gather missing information and ensure accuracy. By creating a detailed action plan, I managed to address the gaps systematically, resulting in a comprehensive submission that met all regulatory requirements.

4:Can you provide an example of how you’ve managed change control in a regulatory context? Answer: In my role, change control management involves tracking modifications made to our products and processes that require regulatory review and approval. For instance, when an alteration in the manufacturing process was proposed, I ensured that all relevant stakeholders were involved. I prepared a comprehensive change control document, detailing the proposed change, its impact on the product, and the regulatory requirements for approval. By managing this process efficiently, we maintained compliance and minimized disruptions to our regulatory timelines.

5: How do you stay updated with evolving regulatory guidelines and their impact on the biopharma industry? Answer: Staying informed about evolving regulatory guidelines is essential in our field. I actively participate in industry conferences, webinars, and workshops that focus on regulatory updates. Additionally, I am part of professional networks and forums where peers share insights and experiences. Regular interactions with colleagues from R&D, quality, and other departments help me understand how regulatory changes might affect our processes. This proactive approach ensures that our submissions are always aligned with the latest requirements, reducing potential delays in approvals.

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