GSK BSc Biological Sciences Regulatory Specialist Job – Apply Online
GSK BSc Biological Sciences Regulatory Specialist Job – Apply Online. BSc Biological Sciences jobs at GSK. GSK Healthcare job openings. Looking for a position as Regulatory Specialist-MSR in GSK, interested and eligible candidates can check out all the details given the same below.
Job title: Regulatory Specialist – MSR Coordination
Job Location: Bengaluru, India
Category: Regulatory
Req ID: 375839
Job description:
Site Name: Bengaluru Luxor North Tower
- 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 :
- With minimal input from manager, executes agreed dossier strategy related to MSR packages
- Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
- 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
- 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.
- Communicates with line manager to identify issues that have business impact.
- May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems.
- Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products,
- Understands internal/external Regulatory environment.
- Actively builds an organizational network.
- 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 guidelines
- Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- 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.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Possible Questions that may be asked for Regulatory Specialist-MSR in GSK
1. Can you tell us about your experience in Regulatory Affairs and your familiarity with drug development processes? Answer: Certainly, I have a Bachelor’s degree in [Biological or Healthcare Science Qualification] and [X] years of experience within the Regulatory Affairs field in the drug development environment. Throughout my career, I have worked on various projects related to Variations, Product Expansion dossiers, Renewals, and regional projects. I have experience authoring and coordinating MSR (Manufacturer Site Readiness) packages for global regulatory submissions, ensuring they meet all necessary requirements.
2. How do you manage multiple project assignments simultaneously while ensuring timely delivery of MSR packages? Answer: Managing multiple project assignments efficiently is crucial in Regulatory Affairs. I prioritize tasks based on deadlines and importance, and I use organizational tools to track progress and deadlines. Regular communication with relevant stakeholders, such as MSR suppliers, helps in obtaining required documentation on time. I am accustomed to handling projects of varying complexities and have a track record of delivering high-quality MSR packages within the specified timelines.
3. How do you stay updated with the changing regulations and guidelines in the pharmaceutical industry? Answer: Staying updated with regulations and guidelines is essential in Regulatory Affairs. I actively participate in industry conferences, workshops, and webinars to gain insights into the latest regulatory developments. Additionally, I regularly refer to reputable regulatory agency websites and subscribe to relevant publications and newsletters. This allows me to interpret and advise on guidelines globally and ensures that our MSR deliverables comply with the most recent GSK standards.
4. Can you describe a situation where you faced a challenging deadline in Regulatory Affairs? How did you handle it? Answer: In a previous project, we had to submit an important Variation dossier with a tight regulatory deadline. To meet the timeline, I proactively organized a cross-functional team, including MSR suppliers and internal stakeholders. I ensured clear communication and defined individual responsibilities to streamline the process. Through effective coordination and diligent work, we successfully prepared the MSR package, met the deadline, and received regulatory approval. This experience taught me the importance of teamwork, time management, and maintaining composure under pressure.
5. How do you ensure the quality and accuracy of your work in preparing MSR packages? Answer: Quality and accuracy are paramount in Regulatory Affairs. I pay meticulous attention to detail throughout the process of compiling MSR packages. I follow established internal and external regulatory guidelines, perform data assessments to ensure fitness for purpose, and identify potential risks associated with submission data. Moreover, I conduct thorough reviews of the documents to ensure they comply with all relevant regulations and GSK standards. Additionally, I am open to feedback from colleagues, which helps in continuous improvement and maintaining the highest level of quality in my work.
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