Senior Scientific Product Lead: Regulatory Strategy

European Medicines Agency; Amsterdam; On-site; EUR 97,000 - 117,000; Full time

Benefits offered by this job

Relocation assistance

Excellent health insurance

Retirement Pension Plan

Expatriation allowances

Education allowances

Job summary

The European Medicines Agency in Amsterdam is seeking a Senior Scientific Specialist (Product Lead) to provide scientific, regulatory and procedural input for human medicines and to lead the product teams for an assigned portfolio.

You will manage lifecycle activities from pre-submission to post-authorisation, contribute to scientific guidelines, and participate in regulatory science projects with the EU network of experts and the European Commission.

Qualifications

• University degree in medicine or life sciences of four years with extensive regulatory experience.
• Experience leading EU/global submission strategies and cross-functional teams.
• Excellent knowledge of EU regulatory landscape and centralised procedure.

Responsibilities

• Portfolio management: coordinate scientific, regulatory and procedural activities across the product lifecycle.
• Lead Product Team activities to align contributors and drive regulatory decisions.
• Identify and mitigate scientific, procedural, and operational risks for assigned products.
• Build relationships with rapporteurs, committee members, experts and stakeholders to support regulatory outcomes.
• Provide regulatory, procedural and scientific support to committees and EU networks.

Skills

Regulatory leadership

Clinical development

Cross-functional coordination

Strategic regulatory guidance

Stakeholder management

Education

University degree in medicine or life sciences (4+ years)

Additional regulatory qualifications (preferred)

Job description

The European Medicines Agency in Amsterdam is seeking a Senior Scientific Specialist (Product Lead) to provide scientific, regulatory and procedural input for human medicines and to lead the product teams for an assigned portfolio.

You will manage lifecycle activities from pre-submission to post-authorisation, contribute to scientific guidelines, and participate in regulatory science projects with the EU network of experts and the European Commission.