Regulatory Affairs Manager jobs in Germany

Regulatory Affairs Manager role at NicheHR Global. Based in UAE.

• Regulatory Compliance: Oversee and manage regulatory activities related to core healthcare products, ensuring compliance with applicable laws and regulations. Interact with Production and Development teams to maintain product supply and help introduce new products. Assess product specifications of the company and its suppliers against customer requirements and government agencies.
• Liaise with auditors and ensure corrective actions and ongoing regulatory compliance.
• Lead regulatory submissions, including preparing and reviewing documents for product registrations and approvals. Ensure no new product is placed on FDA import alerts from legitimate shipments. Maintain all document dossiers for regulatory submissions.
• Serve as primary point of contact for regulatory agencies, building positive relationships to facilitate approvals and compliance.
• Provide expert guidance on US detention regulations and ensure adherence to quality standards across the organization.
• Collaborate cross-functionally with R&D, Quality Assurance, and Legal to integrate regulatory requirements into product development processes.
• Stay abreast of regulatory changes and industry trends; communicate updates to relevant stakeholders.
• Conduct internal audits to assess and enhance regulatory compliance and quality assurance processes.
• Assist in developing and implementing regulatory strategies to support product launches and lifecycle management.

Develop the yearly budget and adhere to it throughout the year in the business context and company profitability.

• Lead and coordinate staff across disciplines to plan, formulate and implement comprehensive regulatory requirements and procedures; foster positive relationships with external agencies.

Experience : Minimum of 12-13 years of progressive experience in core Healthcare Regulatory Affairs, with specific expertise in US detention regulations and Quality compliance. Strong understanding of regulatory requirements for healthcare products in overseas markets (e.g., GCC, EU, UK, USA, Canada, CIS, Trinidad & Tobago, Guatemala, Brazil, Kenya, Russia, Egypt, Uganda, Sudan, Malaysia, Mauritius, Vietnam, Turkey, Yemen, etc.).

Education : Master’s degree in a relevant field (preferred M Pharma, M.Sc. Biotechnologist, Food Tech, etc.).

Skills : Excellent communication and interpersonal skills; ability to lead and collaborate within cross-functional teams; detail-oriented with strong organizational and project management abilities.

• Mid-Senior level

• Full-time

• Health Care Provider

• Personal Care Product Manufacturing
• Hospitals and Health Care