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GSK India
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Submission Specialist

Submission Specialist

GSK India

6 - 13 years

12 - 13 Lacs

Bengaluru

Posted:14 hours ago| Platform:

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Skills Required

Procurement Selection process Middle management Compliance Project management Pharma Healthcare Oncology Regulatory affairs Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

In this role you will work with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), Global Submission Teams and Local Operating Company regulatory contacts to deliver End to End submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs (Standards Operating Procedures) and working practices.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Accountable to the Global Regulatory Lead and Global Regulatory staff for the delivery of lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.
Responsible for the products regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations / renewals / variations , label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc.)
Perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
Liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
Be the contact for the GRL, maintaining the overall workplan (including relevant regulatory milestones according to the phase of development).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor degree or higher in biological or healthcare sciences.
Strong experience within Regulatory Affairs in the Drug development environment and R&D in pharmaceutical industry.
General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV .
Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
Advanced English.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools.

Why GSK?

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 organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

At GSK, we value all perspectives and foster a culture of respect and collaboration within an inclusive environment, focused on the well-being of our team members. If you require any type of accommodation and/or support during the selection process to better showcase your abilities (for example, access to ramps, accessible emergency exits, visual aids, etc.), please let us know when we contact you. We are here to support you.

Your application is voluntary; therefore, you understand and consent that GSK, located at Real Mayorazgo 130, Torre M, Piso 20, Col. Xoco, Benito Ju rez, Mexico City, will process your personal data to evaluate your candidacy in accordance with the candidate privacy notice, which can be consulted at Candidate Privacy Notice . Among the information you provide for this purpose, you may choose to give us personal data that will help ensure an inclusive selection process. Rest assured that your information will be treated with the utmost confidentiality, in compliance with applicable regulations, and will not be available to hiring managers or anyone outside the recruitment team. Help us maintain, together, an inclusive and welcoming environment. By submitting information, I confirm that I agree that it will be processed in accordance with the stated privacy notice.

Important notice to Employment businesses/ Agencies

Find more about life at GSK at www.gsk.com

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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Submission Specialist