Regulatory Affairs Manager

Roles and responsibilities

This role is essential to supporting the growth of the medicinal product portfolio while leading a talented team of regulatory professionals.

Key Responsibilities:

• Manage and lead a team of Regulatory Affairs officers, ensuring timely and efficient regulatory submissions, including Marketing Authorization Transfers, CMC variations, labelling updates, and renewals.
• Act as the primary point of contact with regulatory authorities, ensuring clear and effective communication for all assigned projects.
• Collaborate closely with distribution partners to meet regulatory needs, plan variations, and update marketing authorization dossiers.
• Stay up-to-date with international regulatory guidelines, promoting compliance and best practices across the team.
• Drive process improvements, manage regulatory tools and platforms, and maintain regulatory databases.
• Prepare monthly status reports, project metrics, and workload forecasts to ensure transparency and effective tracking of timelines and budgets.
  
  

The Successful Applicant

The ideal candidate for the role will have:

• A Pharmacy degree or equivalent, with a Master's in Regulatory Affairs.
• 7-10 years of experience in Regulatory Affairs, with a proven track record of team management.
• The candidate needs to be based in UAE with strong experience working in the country
• Experience in a multinational environment, with a focus on regulatory strategy across the Middle East and Asian markets.
• In-depth knowledge of regulatory documentation, time lines, and budgeting.
• Excellent communication and leadership skills, with the ability to thrive in a multicultural environment.
• Fluency in English is required; French and Arabic language skills are a plus.

Desired candidate profile

• Regulatory Knowledge: In-depth understanding of relevant laws, regulations, and guidelines (e.g., FDA, EMA, ISO standards) related to the industry.

• Analytical Skills: Strong ability to analyze complex regulations and assess their impact on products and business operations.

• Attention to Detail: Precision in reviewing documents, submissions, and compliance reports to ensure accuracy and adherence to regulatory requirements.

• Communication Skills: Excellent verbal and written communication abilities for effectively liaising with regulatory agencies, internal stakeholders, and cross-functional teams.

• Project Management: Proficiency in managing multiple projects, timelines, and deliverables while ensuring compliance deadlines are met.

• Problem-Solving Skills: Capability to identify compliance challenges and develop practical solutions to address them.

• Interpersonal Skills: Strong relationship-building skills to collaborate with regulatory agencies, industry groups, and internal departments.

• Strategic Thinking: Ability to align regulatory strategies with business objectives, providing insights that support product development and market entry.

• Continuous Learning: Commitment to staying updated on changes in regulations, industry trends, and best practices in regulatory affairs.

• Risk Management: Understanding of risk assessment and mitigation strategies related to product compliance and market introduction.