Regulatory Affairs Manager

NicheHR Global; Dubai; On-site; AED 200,000 - 300,000; Full time

Job summary

A healthcare consulting company in Dubai is seeking a Regulatory Affairs Manager to oversee regulatory compliance for healthcare products. You will manage submissions, ensure adherence to quality standards, and collaborate with cross-functional teams. The ideal candidate has over 12 years of experience in regulatory affairs, with expertise in US regulations and a Master's degree in a relevant field. This full-time role offers an opportunity to impact product compliance and organizational quality.

Qualifications

• Minimum of 12-13 years of progressive experience in core Healthcare Regulatory Affairs.
• Specific expertise in US detention regulations and Quality compliance.
• Strong understanding of regulatory requirements for healthcare products in overseas markets.

Responsibilities

• Oversee and manage regulatory activities related to healthcare products.
• Lead regulatory submissions and maintain document dossiers.
• Conduct internal audits to enhance regulatory compliance.

Skills

Excellent communication

Interpersonal skills

Project management

Detail-oriented

Education

Master’s degree in relevant field

Job description

Overview

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

Responsibilities

• 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.

Budgets

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

Team Management

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

Experience, Education and Skills

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Personal Care Product Manufacturing
• Hospitals and Health Care