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GSK India
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Submission Lead, Submission Delivery Excellence, Lifecycle Management

Submission Lead, Submission Delivery Excellence, Lifecycle Management

GSK India

5 - 7 years

7 - 9 Lacs

bengaluru

Posted:1 hour ago| Platform:

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Skills Required

procurement delivery excellence interpersonal skills pharma pharmacy focus manager technology oncology hr recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Summary

Are you ready to make a meaningful impact in a dynamic regulatory roleAs a Submission Lead in Submission Delivery Excellence, Lifecycle Management, you will play a key role in ensuring the timely and high-quality delivery of regulatory submissions. You ll collaborate with cross-functional teams to support the lifecycle management of pharmaceutical products, helping us get ahead of disease together. We value candidates who are detail-oriented, proactive, and skilled at building relationships across teams. This role offers opportunities for growth, learning, and contributing to a mission that improves lives worldwide.

Responsibilities

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

Coordinate and deliver regulatory submissions, ensuring compliance with global and local requirements.
Collaborate with cross-functional teams to compile and review submission packages, including Chemistry, Manufacturing, and Controls (CMC) documentation.
Monitor regulatory changes and provide guidance to internal teams on evolving requirements.
Support audits and inspections, ensuring adherence to regulatory and company standards.
Identify opportunities for process improvements and contribute to optimizing regulatory workflows.
Build and maintain strong relationships with internal and external stakeholders to ensure smooth regulatory processes.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

Bachelor s degree in pharmacy, chemistry, biotechnology, or a related field.
Strong understanding of regulatory submission requirements and lifecycle management processes.
Excellent written and verbal communication skills in English.
Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
Attention to detail and commitment to delivering high-quality work.

Preferred Qualification

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

Master s degree in regulatory affairs, pharmacy, or a related field.
Experience working in a matrixed, international environment.
Familiarity with regulatory systems such as Veeva Vault or similar platforms.
Knowledge of global regulatory requirements, including EU and US markets.
Strong interpersonal skills and ability to collaborate effectively across teams.
Demonstrated ability to engage and influence senior stakeholders.

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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Submission Lead, Submission Delivery Excellence, Lifecycle Management