Manager, Regulatory

• Document Management:

  Preparation of Active Substance Master Files, application documents for Certificates of Suitability, and Investigational Medicinal Product Dossiers, along with Quality Overall Summaries/Expert Reports for human medicinal products as part of the marketing authorization dossier.

• Regulatory Compliance:

  Strong emphasis on meeting relevant technical and regulatory requirements, as well as customer-specific demands.

• Strategy and Planning:

  Collaborate with the Business Development team on both new and ongoing projects, supporting the preparation of proposals for clients.

• Project Management:

  Ensure quality, timelines, and customer satisfaction throughout project execution; conduct gap analyses based on requirements.

• Lifecycle Management:

  Provide regulatory support to clients for their products throughout their lifecycle.

• Coordination and Communication:

  Liaise with project teams, customers, internal departments, suppliers, local partners, and regulatory bodies to facilitate essential operational procedures.

• Process Optimization:

  Assist in optimizing internal departmental processes to enhance efficiency.

• Knowledge Sharing:

  Proactively present and distribute relevant technical knowledge, including SOP training for both the organization and clients as required.

• Additional Tasks:

  Handle any other tasks that require regulatory inputs for all types of products across various markets.

Your Profile:

• Graduate / Post-graduate / Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent.
• Minimum of 5 years of professional experience within the pharmaceutical industry in Regulatory Affairs.
• Ability to work autonomously with a focus on quality and detail.
• Strong teamwork skills and a sense of responsibility.
• Excellent command of English.
• In-depth knowledge of current legal and regulatory requirements in developed markets (Japan, USA, and EU).
• Ability to manage and prioritize multiple tasks, especially under tight deadlines.
• Strong organizational and communication skills.
• High degree of social competence with experience in virtual teams and matrix organizations.