Opportunity for Ph.D or M.Pharm, MSc as Regulatory Expert at GSK Rx India

GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000 plus people. Globally, we are a 27.4 billion pound, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.

Post : Regulatory Expert

Job Description :
Job Purpose
• Drives strategy for CMC regulatory submissions. Coordinates timely preparation and authors CMC complex technical regulatory dossiers to support applications for marketing authorisation, lifecycle activities and maintenance of registered pharma and vaccines products in accordance with the applicable regulations and scientific standards.
• Identifies risks associated with submission data and information packages. Ensures adequate contribution and leads CMC Regulatory discussions during interactions with regulatory authorities Worldwide.
• Contributes to the creation, maintenance and continuous improvement of CMC Regulatory processes, policies, instructions, and systems.
• Will serve as a mentor/trainer for new team members.
• Acts as Subject Matter Expert.
• Acts as Technical Dossier Approver.
• Ensures adequate interaction and partnership with the Global Regulatory Lead’s team, PSC, QA, LOCs, 3rd Parties in order to define proper regulatory CMC filing strategy..

Deliverables
• 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 Rx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements.
• Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to teams, Quality Control, PSC, 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).
• Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines.

Candidate Profile
• Bachelor’s degree in Life Sciences or Medical Sciences.
• PhD/Master’s degree or above in Pharmacy, Biotechnology, Biology, Chemistry or closely related science advanced degree.
• Minimum 6-8 years of experience (India specific)
• 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.

Additional Information
Experience : 5+ years
Qualification : Ph.D or M.Pharm, M.Sc
Location : Bengaluru
Req ID : 333202
End Date : 10th May, 2022