Regulatory Affairs Operations

In the Regulatory Affairs Operations role, you will play a pivotal role in driving the strategy and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory submissions, ensuring the timely preparation and authoring of complex technical regulatory dossiers to support marketing authorizations, lifecycle management, and maintenance of registered biopharmaceutical products. Leveraging your expertise, you will identify and mitigate risks associated with submission data and information packages, while leading CMC regulatory discussions during interactions with regulatory authorities worldwide. Additionally, you will contribute to the development, maintenance, and enhancement of CMC regulatory processes, policies, and systems, act as a Subject Matter Expert and Technical Dossier Approver, and serve as a mentor to new team members, fostering a collaborative and high-performing environment. This role requires close partnership and alignment with cross-functional teams, including Global Regulatory Leads, GSC, MSAT, QA, LOCs, and ESQ, to define and implement an effective regulatory CMC filing strategy.

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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Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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