Looking for a opportunity in GSK…! Check out the position namely, Regulatory Specialist in GSK. Interested and eligible candidates can check out all the details given the same below.
Job title: Regulatory Specialist – MSR Coordination
Location: Bengaluru, India
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
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
Qualifications we seek in you for Regulatory Specialist in GSK!
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.
Possible interview Questions may be asked for Regulatory Specialist in GSK
1: Can you explain your understanding of regulatory compliance and its importance in our industry?
Answer: Regulatory compliance is the adherence to laws, regulations, and guidelines that govern our industry. It ensures that products, processes, and operations meet the required standards to ensure safety, efficacy, and quality. It is crucial in our industry as it helps protect consumers, fosters public trust, and enables us to bring innovative products to market while maintaining high ethical and safety standards.
2: How do you stay updated with the latest regulatory changes and updates?
Answer: As a Regulatory Specialist, staying updated with regulatory changes is vital. I regularly monitor regulatory agencies’ websites, subscribe to industry newsletters, and participate in professional development seminars and conferences. Networking with regulatory professionals and engaging in continuous education helps me stay informed about evolving regulations and best practices.
3: Can you describe a challenging regulatory approval process you have managed, and how did you handle it?
Answer: In a previous role, we encountered a complex regulatory approval process for a new medical device. To handle this challenge, I assembled a cross-functional team, including R&D, quality, and legal experts, to collaborate on compiling comprehensive data and documentation. We ensured compliance with all relevant regulations, communicated effectively with the regulatory authorities, and addressed any concerns promptly. This proactive approach resulted in a successful regulatory approval.
4: How do you handle instances when there are conflicting regulatory requirements from different countries?
Answer: Dealing with conflicting regulatory requirements can be challenging. I first conduct a thorough analysis of the regulations from each country and identify areas of overlap or differences. Then, I work closely with regulatory experts and legal advisors to develop a compliance strategy that aligns with the highest standards while meeting each country’s specific requirements. Open communication and transparency with relevant stakeholders help ensure a cohesive and compliant approach.
5: How do you ensure that our company’s products and processes are compliant with all applicable regulations?
Answer: Ensuring compliance requires a comprehensive approach. I establish a robust regulatory framework, including standard operating procedures and guidelines for each product and process. Regular audits and internal reviews are conducted to assess compliance and identify areas for improvement. Collaboration with cross-functional teams ensures that all departments are aligned with regulatory requirements, and continuous training programs help raise awareness and maintain a culture of compliance.
