Regulatory Affairs Officer

Job description / Role

We are currently seeking a Regulatory Affairs Officer to be based in Abu Dhabi, UAE.

We are looking for a highly motivated and professional team player with at least 3 years of professional experience in in a similar position in a pharmaceutical company.

The Regulatory Affairs Officer will be responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals.

He/She will also ensure ethical conduct and compliance with applicable national and international laws, codes and regulations.

In addition to regulatory affairs responsibilities the incumbent is responsible for market access responsibilities. In this role, the individual will evaluate and assess the implications our products may have on a wider healthcare market. Map decision making processes and develop best practices with the intention to prepare a positive healthcare environment.

Regulatory Affairs Officer Responsibilities:
• Ensure fast registration and reimbursement of products, updating existing files, through continuous coordination between RA teams and agents, as well as health authorities.
• Develop and maintain a product database of all products’ regulatory status in the region and ongoing registration. Define the priority of each project (product - market) based on corporate strategy and Regional Specificities.
• Implement the regional drug safety and pharmacovigilance policies, in line with local and international Regulations, Corporate guidelines and the regional policy.
• Establish and maintain good relationships with Ministry of Health, Regulatory authorities and Pharma associations, ensuring optimum visibility and priority for product registration.
• 5.Control timelines (submissions – approvals- introductions) to cope with regional plans & strategies as well as production plans and capacity through proactive communications with all relevant parties
• Identify key decision-making processes that facilitate market access at each step, - e.g. pricing, reimbursement, formulary access, funding and uptake – for a new or currently reimbursed technology as well as the key influencers and stakeholders. Identify the information needs of the various customer groups and other stakeholders.
• Build and develop a network with reimbursement related stakeholders including decision-makers, influencers, associations and other interest groups such as Key Opinion Leaders.
• Advise business units on market access strategies and assist with message mapping and strategy outline. Make Recommendations based on economic and outcomes data required. Work on pricing and positioning strategy to optimize the commercial potential of a health care technology or product.
• Track effective budget expenditure within approved budget guidelines.

Requirements

Competency/Technical Skills:
• Extensive knowledge of RA environment (processes, organization, legislation) in the Middle East
• Highly organized with a keen sense of what it takes to get the job done; strong operating skills and a sense of urgency.
• Must have strong collaborations skills; the ability to work in a matrix organization and experience working in a partnership environment, excellent in influencing others without direct hierarchic link.
• Strong mental agility and motivation are required to deal with the variety of therapeutic indications, product segments and market access strategies.
• Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach.
• Ability to build and influence external contacts

Experience:
• Minimum 2 years of experience in Regulatory Affairs position in a pharmaceutical company Previous regional experience is preferred
• Background in MOH and and HAAD regulatory procedure

Education
• Pharmacy Degree, Health Economics or Medical Related Sciences

About the Company

Black Pearl is a human resources and recruitment agency that provides a holistic business and talent solution in a progressive, dynamic, and efficient way.

We pride ourselves as a unique black pearl and strive to delight our clients with a personalized partnership that helps them propel towards success.

Whether you need to find top talent, your next great job opportunity, or a consulting solution for managing your business, engaging employees, evolving your work culture, planning your people strategy, or resourcing challenges, we can help.