Global Post-Marketing CMC Regulatory Strategist

Gi Group (United Kingdom); Basel; Presencial; CHF 100 000 - 150 000; Tempo integral

Resumo da oferta

Gi Group is seeking a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR) based in Basel, Switzerland, to lead global regulatory submissions for clinical and commercial products. The role emphasizes post-approval maintenance, lifecycle management, and proactive regulatory strategy with cross-functional teams.

You will collaborate with affiliates and policy teams, drive adherence to global guidelines, and help streamline processes in a fast-moving regulatory landscape.

Qualificações

• Minimum Bachelor degree within a relevant field.
• 3-4 years of CMC regulatory and technical regulatory experience.
• Fluent in verbal and written English (C1).
• Experience with post-approval regulatory maintenance and legacy data cleanup.
• Strong experience with commercial product support and post-marketing submissions.
• Proactive problem-solving to streamline records and ensure compliance.
• Proficient with Veeva RIM environment.

Responsabilidades

• Global Submission Management: manage and execute global regulatory submissions for clinical and commercial products.
• CMC Lifecycle & Change Control: oversee end-to-end regulatory lifecycle and maintain CMC docs in system like Veeva.
• Cross-Functional Representation: act as PTR representative on cross-functional project teams.
• Regulatory Compliance & Strategy: develop strategies for early CTA approvals and lifecycle extensions.
• Agency & Partner Interactions: direct communications with regulatory authorities and partners.
• Operational Excellence: identify regulatory risks and streamline tracking and processes.
• Regulatory Intelligence: monitor global guidelines and assess impacts on portfolios.

Conhecimentos

English proficiency

Veeva RIM

Regulatory submissions

Cross-functional collaboration

Problem solving

Formação académica

Bachelor degree in a relevant field

Ferramentas

Veeva RIM

Descrição da oferta de emprego

Gi Group is seeking a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR) based in Basel, Switzerland, to lead global regulatory submissions for clinical and commercial products. The role emphasizes post-approval maintenance, lifecycle management, and proactive regulatory strategy with cross-functional teams.

You will collaborate with affiliates and policy teams, drive adherence to global guidelines, and help streamline processes in a fast-moving regulatory landscape.