GlaxoSmithKline Hiring 2022 Bachelor’s degree for Consultant- Regulatory Specialist -RIM At Bengaluru, India . GlaxoSmithKline Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: Consultant- Regulatory Specialist -RIM
- Qualification: Bachelor’s degree
- Experienced:0 to 3 years
- Openings:NA
- Salary:NA
Job Description: GlaxoSmithKline Hiring For Consultant- Regulatory Specialist -RIM !
- Important Details :
- Location: Bengaluru, India
- Note:you should disregard the same and inform us by emailing askus@gsk.com
- Post of date: 18/05/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
Ready to help shape the future of healthcare?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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 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 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 established regulatory information management system(s).
- Supporting Legal and Business Development project work for document discovery, in-licensing, and out-licensing initiatives.
- Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.
- Working on Special projects as required in response to internal and external customer requests.
- Support for IT related activities
Knowledge/ Education / Previous Experience Required*
A. 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 complex technical environment within a scientific organisation
2. Preferred Level of Education – Masters degree or higher in biological or healthcare science
Area of Specialisation – Chemistry, pharmacy or other related science or regulatory affairs. Project Management, Communication
Why is this Level of Education Preferred? – The ability to interact confidently with highly-educated staff, customers and partners in a complex technical environment will be a significant advantage in this role
B. Job-Related Experience
Minimum Level of Job-Related Experience required :-
- 0-3 years’ experience in delivering business operational support (in 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, 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
Why is this Level of Experience Required? – Competency in the use of regulatory information management tools and sound understanding of the procedures and standards is required to work independently and to quality check others’ work
C. Other Job-Related Skills/Background
Application of Knowledge – Knowledge of the systems and related procedures used is required to efficiently complete tasks meeting requirements.
Problem Solving & Innovation – Need to be able to analyze inputs received to ensure they meet data standards prior to entry; need to know when to question the mentor or the requestor and ask questions about the data.
Interaction – May need to interface with requestors (who may be in any part of the organization) to gain clarity of work requested.
Impact – The information managed 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.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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