GSK Regulatory Specialist Job Opening – Pharma Candidates Apply Online
GSK Hiring pharm candidates for Regulatory Affairs, Regulatory Affairs, job opening 2022. Pharma job opening 2022. Pharmacy job opening 2022. Regulatory Affairs, job opening 2022. Candidates with bachelor’s and master’s degree in pharma may apply for the job opening at GSK. Check out all the details on the same below:
Job Title: Regulatory Specialist II – RIM
Location: Bengaluru, India
Department: Regulatory
Job Id: 332467
Knowledge/ Education / Previous Experience Required:
Educational Background
1. Minimum Level of Education – Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
Area of Specialisation: Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication
Why is this Level of Education Required? : Working in the complex technical environment within a scientific organization
2. Preferred Level of Education – Masters’s degree or higher in biological or healthcare science
Job-Related Experience
Minimum Level of Job-Related Experience required :
- 0-3 years experience in delivering business operational support (in the pharmaceutical industry, life sciences research or regulatory). Have worked on regulatory submission, have fair knowledge on the CAPA and audit reports
- Demonstrated ability to proactively manage workload, and timelines and identify priorities. Build relationships with relevant internal functions.
- Proven ability to work on multiple projects simultaneously.
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Has worked successfully with a complex computer system
- Interacts with customers to ensure compliance with regulatory records and data management requirements
Job Purpose:
Ensures that GSK portfolio of product registration information is maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply. This data also supports the efficient operational management of the Regulatory function, worldwide. The role provides operational support to RIMS end-users.
Key Responsibilities:
The information (data and documents) managed by Regulatory Information Management is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK. The role provides operational support to Regulatory Information Management Systems (RIMS) end-users.
Responsibilities of this role are:
- Accurate completion of routine data maintenance tasks to agreed schedule
- Ensure own work is compliant with data standards and defined procedures
- Ensure defined quality control procedures are followed and appropriate actions are taken following any issues identified during routine quality monitoring activities.
- Capable of performing routine data extraction from RIMS to support KPI generation
- Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and revised procedures to improve quality and effectiveness
- Indexing, abstracting, and quality assurance of English and non English submissions and associated correspondence into the established regulatory information management system(s).
- Supporting Legal and Business Development project works for document discovery, in-licensing, and out-licensing initiatives.
- Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using online databases.
- Working on special projects as required in response to internal and external customer requests.
- Support for IT related activities
Apply Online
Editors Note: GSK Regulatory Specialist Job Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
