GSK Looking for Regulatory Specialist III at Karnataka Full Time

Site name: bengaluru luxor north tower
Posted date: mar 30 2022

Job description

This section may be extracted by the department and used for the purposes of recruitment, training records, etcThe authors/approvers box at the end of this section enables the employee and line manager to agree understanding of the role, if required for regulatory purposes, and should be completed only after the job evaluation process is complete and grade is confirmed.

Job title*

Regulatory specialist, rim – iii, ii (in)/ junior regulatory specialist, rim (pl,)

Dept

Grc

Line manager job title*

Senior manager- rim (in, pl)/manager rim (in, pl, mx) or center head, grc mexico

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 supplyThis data also supports the efficient operational management of the regulatory function, worldwideThe role provides operational support to rims end-users.

Key responsibilities (10 bullet points maximum)

Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role

The information (data and documents) managed by regulatory information management is critical to patient safety, regulatory compliance and effective business operationsThe 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 gskThe 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 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

Breadth/ scope of accountability
Provide details of any scope data relevant to the role e.gThe net sales that the role supports / generates or budget responsibility.

Number of direct reports

None

Number of indirect reports

None

Annual budget managed by this role (provide either revenue/ assets managed or operating budget)

Annual direct revenue accountability
(please add currency)

Not applicable

Assets managed, if applicable

(please add currency)

Not applicable

Operating budget accountability,
If applicable
(please add currency)

Not applicable

Knowledge/ education / previous experience required

AEducational background
List any academic or practical education that must be obtained to be qualified to perform this role.

1Minimum 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 affairsProject management, communication

Why is this level of education required?

Working in complex technical environment within a scientific organisation

2Preferred level of education

Masters degree or higher in biological or healthcare science

Area of specialisation

Chemistry, pharmacy or other related science or regulatory affairsProject 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

BJob-related experience
Describe what experience this position will require the job holder to have obtained in past roles within or outside of gsk that would demonstrate a level of proficiency in the stated role.

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 prioritiesBuild 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

COther job-related skills/background
List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in educational background or job-related experience sections above that are required for the job.

Service orientation, customer-focused
Ability to work carefully under time constraints
Excellent attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
Demonstrated ability to think flexibly to meet constantly shifting priorities and timelines.
Relevant experience in a regulatory environment, specifically data and information management, including indexing, abstracting, information searching or information technology experience
Knowledge of record retention procedures and business practices regarding regulatory document management.
Demonstrates the following behaviors:

Enable and drive change
Ability to work carefully under time constraints and prioritize accordingly
Good team worker whilst working in a remote environment

Proficient in basic pc software applications, including ms word, ms excel, adobe acrobat or related software.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companiesWe believe that we all bring something unique to gsk and when we combine our knowledge, experiences and styles together, the impact is incredibleCome join our adventure at gsk where you will be inspired to do your best work for our patients and consumersA place where you can be you, feel good and keep growing.

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