Latest Medical Affairs Partner - Nephrology & R Jobs

Director, CMC Regulatory Affairs

Leads global CMC regulatory strategy for small molecule medicines, working across R&D, supply, quality, and commercial functions to ensure regulatory compliance and uninterrupted patient supply. Provides strategic direction on regulatory submissions, mentors regulatory staff, and engages with global authorities. Focuses on solving complex regulatory challenges while aligning with business objectives and patient impact.

GSK

Hybrid Permanent

Regional Regulatory Manager

The Regional Regulatory Manager leads the development and execution of regional regulatory strategies for assigned assets, ensuring alignment with global goals and regional requirements. This role involves close collaboration with global and local teams, providing regulatory expertise, anticipating risks, and driving timely submissions and approvals.

GSK United Kingdom

Hybrid Permanent

Senior CMC Regulatory Strategy Manager

Leads CMC regulatory strategy for biopharmaceutical development and lifecycle management, coordinating technical submissions and ensuring compliance with global regulations. Works cross-functionally to address complex CMC issues, support inspections, and influence regulatory decisions. Focuses on maintaining product supply and optimizing regulatory processes across international markets.

GSK £144,375 – £240,625 pa

Hybrid Permanent

Senior CMC Regulatory Strategy Manager

Leads CMC regulatory strategy for biopharmaceutical development and lifecycle management, ensuring compliance with global regulations and supporting submissions, inspections, and supply continuity. Works cross-functionally to shape regulatory approaches and mentor teams, with a focus on innovation and risk mitigation in complex regulatory environments.

GSK €90,000 – €150,000 pa

Hybrid Permanent

Senior CMC Regulatory Strategy Manager

Leads CMC regulatory strategy for biopharmaceutical development and lifecycle management, coordinating technical submissions and advising on global regulatory requirements. Works cross-functionally to ensure compliance, support inspections, and maintain product supply. Focuses on shaping regulatory approaches and mentoring teams in a complex, science-driven environment.

GSK €90,000 – €150,000 pa

Hybrid Permanent

Senior CMC Regulatory Strategy Manager

Leads CMC regulatory strategy for biopharmaceutical development and lifecycle management, coordinating technical submissions and advising on global regulatory requirements. Works cross-functionally to ensure compliance, support inspections, and maintain product supply. Focuses on risk mitigation, process improvement, and influencing regulatory decisions across complex international environments.

GSK £144,375 – £240,625 pa

Hybrid Permanent

SERM Medical Director

The SERM Medical Director at GSK leads the safety evaluation and risk management of oncology assets in clinical development. Key responsibilities include interpreting safety data, managing safety signals, and providing expert medical input to support benefit-risk decisions. This role involves leading cross-functional teams, collaborating with regulatory authorities, and shaping the safety strategy for innovative oncology medicines.

GSK

On-site Permanent

SERM Associate Medical Director

This role involves providing medical and scientific expertise in safety evaluation and risk management for GSK's clinical and post-marketing assets. Responsibilities include signal detection, data analysis, and communication of safety risks, as well as supporting safety governance and cross-functional teams.

GSK United Kingdom

Hybrid Permanent

Principal Medical Writer

This role involves authoring and delivering high-quality clinical regulatory documents, leading cross-functional teams, and managing complex writing projects. The Principal Medical Writer will interpret clinical and statistical data, ensure compliance with regulatory requirements, and contribute to global regulatory submissions.

GSK Stevenage, United Kingdom

Hybrid Permanent

Principal Medical Writer

The Principal Medical Writer will lead the creation of high-quality clinical and regulatory documents, working closely with cross-functional teams to ensure scientific rigor and clear communication. This role involves strategic planning, project management, and translating complex data into clear narratives, with a focus on regulatory compliance and process improvement.

GSK United States

On-site Permanent

Principal Medical Writer

The Principal Medical Writer will lead the creation of high-quality clinical and regulatory documents, working closely with cross-functional teams to ensure scientific rigor and compliance. This role involves strategic planning, project management, and translating complex data into clear narratives, with a focus on regulatory submissions and process improvements.

GSK

On-site Permanent

Principal Medical Writer

The Principal Medical Writer will author and deliver high-quality clinical regulatory documents, lead cross-functional teams in developing clinical dossier documents for global regulatory submissions, and manage complex writing projects. They will interpret complex clinical and statistical information, ensuring compliance with GSK standards and regulatory requirements.

GSK

Hybrid Permanent

Director Medical Writing Process Management

The Director Medical Writing Process Management will lead the optimization of end-to-end business processes within Medical Writing, ensuring compliance, efficiency, and continuous improvement. They will collaborate with cross-functional teams to implement best practices, monitor process health, and align with GSK’s strategic goals.

GSK Stevenage, United Kingdom

On-site Permanent

SERM Medical Director

The SERM Medical Director role at GSK involves providing in-depth medical and scientific expertise in safety evaluation and risk management for key GSK assets. Responsibilities include leading pharmacovigilance, developing safety strategies, and ensuring compliance with regulatory standards. The role also involves cross-functional team leadership, communication of safety issues, and contributing to the continuous improvement of safety processes.

GSK United Kingdom

On-site Permanent

SERM Scientific Director

This role involves leading pharmacovigilance and risk management for GSK's global assets, ensuring scientifically sound review and interpretation of safety data. The director will develop and execute safety strategies, manage safety governance, and lead cross-functional teams to address product safety issues and ensure patient safety globally.

GSK

On-site Permanent