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GSK India
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Regulatory Project Manager

Regulatory Project Manager

GSK India

6 - 7 years

35 - 45 Lacs

bengaluru

Posted:21 hours ago| Platform:

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Skills Required

procurement pharma project management cms cmc healthcare oncology manager quality control subject matter expert continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

You will also drive continuous improvement by enhancing CMC regulatory processes, policies, and systems while serving as a Subject Matter Expert and Technical Dossier Approver. As a mentor, you will help onboard and develop new team members, fostering a collaborative and high-performing environment. Success in this role relies on strong cross-functional collaboration with teams such as Global Regulatory Leads, GSC, MSAT, QA, LOCs, and ESQ to define and implement effective regulatory CMC filing strategies.
Key Responsibilities:

Independently assesses, manages, and/or drives the CMC strategy, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Biopharm portfolio in accordance with the applicable regulatory and scientific standards, considering the evolving regulatory requirements.
Understands internal and external Regulatory environment with the ability to provide guidance to R&D teams, Quality Control, GSC, QA and LOC.
Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.
Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions.
Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities.
Mentors and/or trains staff, develop Subject matter experts (SMEs) within team by providing guidance and relevant knowledge.
Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.
Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems. Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.
Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary to influence CMC project and policy issues that are aligned with GSK business needs ensuring optimum position for GSK. May represent GSK externally (e.g. Audits, Conferences, External Forums).

Basic Qualifications:

Around 6-7 years of experience
Sound knowledge and understanding of drug development and manufacturing and supply processes and may have a specialized area of expertise.
Demonstrated ability to handle complex global CMC submissions and issues through continuous change and improvement.
Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Proven project management and multi-tasking skills.
High ability to manage matrix teams and direct multiple projects.
Experience in influencing and negotiating with GSK personnel in a variety of settings.

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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Regulatory Project Manager