Graduate Intern – CMC RA, Delivery, Small Molecules Mature Products

• Authors multiple CMC technical regulatory documents to support applications for marketing authorization, lifecycle activities, and maintenance of registered products in accordance with the applicable regulatory and scientific standards. Use digital platforms (e.g. RIM, structured data tools) to execute regulatory activities and ensure high quality regulatory data.
• With management oversight, ensuring data and information packages are fit for purpose.
• Identifies risks associated with submission data and information packages.
• Communicates clearly with line manager to identify issues that have business impact.
• Develops an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
• Understands internal/external Regulatory environment.

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy

 

 

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.

Inclusion at GSK:

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