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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Post : Regulatory Project Manager Regional Projects CD CMC
Job Description
Job Purpose : Manages the CMC regulatory activities of multiple projects and dosage forms and represent the Regulatory group across business and organizational boundaries.
Key Responsibilities :
Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines. Independently assesses, manages, and completes multiple complex projects simultaneously. Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches. Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, issues that have business impact. Serves as dossier reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems. Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. Utilizes established internal and external organizational networks Communicates complex regulatory issues independently 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. Demonstrates flexible thinking, continuous improvement and is customer driven.
Candidate Profile
• Sound knowledge of drug development and manufacturing and supply processes.
• Detailed knowledge of worldwide CMC regulatory requirements and experience with regulatory submissions across the product lifecycle.
• Successfully managed multiple projects simultaneously.
• Continued professional growth in global Regulatory Affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across Regulatory functions to understand wider implications of emerging issues across projects.
• Experience in influencing and negotiating with GSK personnel in a variety of settings.
• Highly developed interpersonal, presentation, and communication skills with established internal and external networks.
Additional Information
Location : Bengaluru Luxor North Tower
Req ID : 391461
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th March, 2024
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