Europe Regulatory Affairs Executive — Lifecycle & Compliance

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Viatris is seeking an experienced Regulatory Affairs professional to lead regulatory activities across Europe, collaborating with cross-functional teams and health authorities to ensure registrations and lifecycle management. The role requires strong communication and knowledge of European procedures.

You will support affiliate teams, maintain regulatory documentation, and contribute to regulatory strategy while ensuring compliance and timely submissions across the product portfolio.

Qualificações

• A degree in Pharmacy, Biotechnology, Life Sciences, or a related scientific discipline.
• 2–3 years of Regulatory Affairs experience within the pharmaceutical industry.
• Knowledge of European regulatory procedures and lifecycle management.
• A Master's qualification in Regulatory Affairs would be advantageous.
• Strong communication and stakeholder management skills.
• Excellent organisational skills and attention to detail.
• Fluent English, both written and spoken.

Responsabilidades

• Manage regulatory activities for a portfolio of pharmaceutical products across Europe.
• Prepare and submit regulatory applications, variations, renewals, and lifecycle management activities.
• Support new product registrations through European and national regulatory procedures.
• Collaborate with European affiliate teams to ensure successful implementation of regulatory strategies.
• Maintain regulatory databases and documentation to ensure ongoing compliance.
• Build strong relationships with internal stakeholders and external business partners.
• Support interactions with regulatory authorities and contribute to responses to health authority queries.
• Monitor regulatory developments and assess their impact on the product portfolio.

Conhecimentos

Regulatory Affairs

Stakeholder management

Regulatory submissions

Communication skills

Formação académica

Bachelor in Pharmacy or Life Sciences

Master's in Regulatory Affairs (advantageous)

Descrição da oferta de emprego

Viatris is seeking an experienced Regulatory Affairs professional to lead regulatory activities across Europe, collaborating with cross-functional teams and health authorities to ensure registrations and lifecycle management. The role requires strong communication and knowledge of European procedures.

You will support affiliate teams, maintain regulatory documentation, and contribute to regulatory strategy while ensuring compliance and timely submissions across the product portfolio.