Senior Regulatory Affairs Manager – Innovative Pharma

Location:

Amsterdam – Noord-Holland, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

131934850

Posted On:

22 May 2025

Job Title: Senior Manager, Regulatory Affairs
Location: Hoofddorp, The Netherlands
Reports to: Vice President, Global Regulatory Affairs – Specialty Business
Direct Reports: None (may supervise RA Associate depending on experience)

Key Responsibilities:

Lead Regulatory Affairs for branded portfolio in Europe.
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Develop and execute regulatory strategy aligned with Target Product Profiles (TPPs) and business goals.
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Prepare and manage EU Marketing Authorization Applications (MAAs), Scientific Advice, PIP, and ODD procedures.
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Ensure regulatory compliance post-authorization in line with EU regulations (e.g., 2001/83/EC, 726/2004).
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Act as the primary contact with EU health authorities, responsible for high-quality submissions and interactions.
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Oversee product artwork, advertising, educational materials, and ensure compliance.
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Collaborate cross-functionally with teams such as Medical Affairs, PV, R&D, Quality, Supply, Market Access, and more.
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Minimal travel requirements (max. 20%, mostly within Europe).
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Operate with high autonomy, reporting to a US-based manager with a non-micromanaging style.

Scope:

Full responsibility for regulatory strategy and execution in both pre- and post-authorization phases.
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Interface with local affiliates, external consultants, and service providers.
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Support due diligence and business development activities.
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Lead or contribute to SOP development, regional implementation, and labeling/SmPC/PIL updates.

Qualifications:

Bachelor’s degree or higher in Pharmacy, Chemistry, or Life Sciences.
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8+ years of experience in Regulatory Affairs, with at least 5+ years in Branded/NCE products.
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Strong knowledge of EU regulatory procedures, including CP, national procedures, Article 8(3), Article 10(3).
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Experienced in clinical development strategy, MA submissions, and lifecycle management.
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Familiarity with GMP, GDP, GVP, GCP, and Clinical Trial Regulation.
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Excellent project management, leadership, and communication skills.

Behavioral Competencies:

Strategic thinker, accountable, solution-oriented.
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Strong communicator with the ability to collaborate cross-functionally and influence stakeholders.
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Proactive, flexible, and committed to continuous improvement.
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Customer-focused, performance-driven, and capable of navigating matrix environments.

Why Join :

High-impact role with autonomy and influence on global strategy.
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Work in a growing, innovative environment focused on patient benefit.
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90-110k per annum, full benefits, and a hybrid model (2 days office, 3 days remote).

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