BSc Biological Sciences GSK Job Opening – Apply Online For Regulatory Specialist Post

BSc Biological Sciences GSK Job Opening – Apply Online For Regulatory Specialist Post

BSc Biological Sciences GSK Job Opening – Apply Online For Regulatory Specialist Post. At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. Regulatory Specialist – MSR Coordination opening details are provided below. Apply online if you are interested for BSc Biological Science Job.

Role: Regulatory Specialist – MSR Coordination

Location: Bengaluru, India

Site Name: Bengaluru Luxor North Tower

Req ID – 378526

Job description:

• Provides support for GRA regulatory delivery activities (e.g., Variations, Product Expansion dossiers, Renewals and regional projects) of assigned projects with management input.
• Supports Global Regulatory by authoring and coordinating appropriate MSR packages for global regulatory submissions with appropriate guidance from supervisor, as necessary.
• May have training responsibilities for new staff on established departmental processes.

Key Responsibilities :

1. With minimal input from manager, executes agreed dossier strategy related to MSR packages
2. Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
3. With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity
4. With minimal input from manager, completes data assessment to ensure MSR package is fit for purpose, identifies risks associated with submission data and MSR packages.
5. Communicates with line manager to identify issues that have business impact.
6. May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems.
7. Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products,
8. Understands internal/external Regulatory environment.
9. Actively builds an organizational network.
10. Communicates across GSK, with minimal input from manager regarding projects and new requirements impacting MSR deliverables

Educational Background:

• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
• Chemistry, pharmacy or other related science or technical bachelors degree.

Job-Related Experience:

• Minimum 1- 5 years of relevant experience
• Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
• Proven ability to work on multiple projects simultaneously.
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Global/ EMAP Regulatory submission experience – Knowledge of regulatory agency guideline
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadline
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
• Ability to build effective working relationships and work in a matrix environment effectively
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.

APPLY ONLINE

Hello, you can go through the following interview question and answers during the preparation for the BSc Biological Science Job. Good luck with your interview.

Question 1: Can you provide an example of a complex regulatory submission project you’ve managed? How did you approach the coordination of MSR packages for such a project? Answer: In my previous role at XYZ Pharmaceuticals, I was responsible for coordinating a complex regulatory submission involving multiple variations and regional projects simultaneously. I collaborated closely with MSR suppliers, such as GMS and External Supply QA, to gather the necessary documentation. I also conducted a thorough data assessment to ensure the MSR package was robust and aligned with regulatory requirements. Throughout the project, I maintained effective communication with my manager, providing updates on progress and identifying potential risks. By proactively managing timelines and priorities, I successfully delivered the MSR package on time and ensured its compliance with regulations.

Question 2: How do you ensure that you stay updated on the changing regulatory guidelines and requirements in the pharmaceutical industry? Answer: I recognize the importance of staying current with regulatory changes, and I actively engage in continuous learning. I regularly participate in industry conferences, webinars, and workshops to gain insights into evolving guidelines and requirements. Additionally, I subscribe to regulatory newsletters and follow reputable regulatory agencies’ updates, such as those from FDA and EMA. This commitment to staying informed ensures that I can interpret and apply the most recent regulatory guidance to my work.

Question 3: Describe a situation where you had to manage conflicting priorities while working on multiple projects. How did you handle it? Answer: In my previous role, I encountered a scenario where I was tasked with managing multiple projects, all with tight deadlines. To handle the conflicting priorities, I first assessed the urgency and importance of each project. I then communicated with my manager and relevant stakeholders to prioritize tasks effectively. I created a detailed timeline, allocating sufficient time to each project based on its complexity and regulatory requirements. By maintaining open communication, setting clear expectations, and re-evaluating priorities when necessary, I successfully managed the workload and delivered all MSR packages on time.

Question 4: Can you provide an example of a time when you identified an improvement opportunity in regulatory processes? How did you address it? Answer: At my previous organization, I noticed that there was a gap in the efficiency of document retrieval for MSR packages. To address this, I proposed implementing a streamlined documentation management system. I collaborated with the IT department to develop a digital repository that categorized documents based on submission type and regulatory region. This enhancement significantly reduced the time spent searching for documents and improved overall coordination. It was well-received by the team and led to a more efficient regulatory submission process.

Question 5: How do you handle situations when unexpected changes or challenges arise during the preparation of regulatory submissions? Answer: I understand that unexpected challenges are inherent in regulatory work. When facing such situations, I adopt a flexible and proactive approach. I first assess the impact of the change on the project’s timeline and regulatory compliance. I then communicate with relevant stakeholders, including my manager, to discuss the situation and identify potential solutions. By collaborating closely with the team, adapting my plans as needed, and maintaining clear communication, I ensure that any challenges are addressed promptly and that the MSR packages remain on track for successful submission

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