European Regulatory Affairs Lead: Strategy & Approvals

NoxPharm; Lisboa; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Viatris Europe seeks a Regulatory Affairs Manager - Central Regulatory Affairs to lead European regulatory strategy and submissions for a diverse portfolio. You will ensure timely approvals, licence maintenance, and ongoing EU compliance, coordinating with Global RA functions and external partners.

The role requires a university degree in Pharmacy or related field, 5+ years RA experience, fluent English, and strong interpersonal skills.

Qualificações

• University degree in pharmacy, biotechnology or related field.
• 5+ years regulatory affairs experience in the pharma sector.
• Fluent English, both written and spoken.
• Strong interpersonal and cross-functional collaboration skills.

Responsabilidades

• Lead regulatory strategy across European markets and submissions.
• Ensure timely approvals, licence maintenance, and EU compliance.
• Coordinate submissions with internal teams and external partners.
• Provide regulatory guidance to clinical, quality and commercial functions.
• Liaise with EMA and national authorities for product registrations.
• Mentor and develop junior regulatory staff in the team.

Conhecimentos

Regulatory strategy

EU regulatory requirements

Stakeholder collaboration

Communication skills

Fluent English

Formação académica

Bachelor's degree in Pharmacy/Biotechnology or related field

Masters in RA preferred

Descrição da oferta de emprego

Viatris Europe seeks a Regulatory Affairs Manager - Central Regulatory Affairs to lead European regulatory strategy and submissions for a diverse portfolio. You will ensure timely approvals, licence maintenance, and ongoing EU compliance, coordinating with Global RA functions and external partners.

The role requires a university degree in Pharmacy or related field, 5+ years RA experience, fluent English, and strong interpersonal skills.