REGULATORY AFFAIRS SPECIALIST
About the job
The Position: Regulatory Affairs Specialist
The Regulatory Affairs Specialist is responsible for the overall regulatory compliance and the licenses for the operation of the company . His/her duty primarily has the day-to-day responsibility directly for assigned regulatory submissions.
Duties & Responsibilities
• Maintain the company activity license in order to assure business continuity
• Maintain all Authorized Representative Agreements with the respective global legal manufacturers
• onboard, train, develop and retain talent on the assigned Affiliate Regulatory Affairs team.
• Prepares, reviews and manages submissions for affiliate regulatory approvals
• Oversee and manage Regulatory Affairs operations and set goals, ensure that they are met and is responsible for continuous process improvement of the assigned Affiliate staff (co-review, advice).
• Maintains expert knowledge of Saudi regulatory requirements for IVDs/medical devices for initial clearance, registration, re-registration and post-approval changes
• Gather and disseminate regulatory intelligence within the Affiliate; involving regional and global organizations, when appropriate.
• Provided scientific and regulatory guidance to assure that the information available will meet regulatory expectations of SFDA
• Provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.).
• Develop innovative, risk-based regulatory strategies and work plans for assigned products or business areas within the Affiliate to accelerate access in alignment with global.
• Interact and negotiate with stakeholders (meetings, calls, emails, and visits)for successful regulatory outcomes.
• Interaction with commercial and supply to ensure business continuity (submission strategy for regulatory filings, and Import license).
• Support regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits (by ensuring the proper achieving, system accurate, and timely manner entries).
• Supervise and manage relevant Affiliate regulatory activities on applicable systems to ensure appropriate, thorough, and timely regulatory information and documentation management.
• Supervise and manage end-to-end local product packaging, labeling and relabeling from a regulatory perspective.
Skills & Knowledge
• Ability to work cooperatively and productively with others.
• Strong written and oral communication skills
• Fluency in communication in both languages (English & Arabic).
• Demonstrable team working abilities/skills as it involves internal and external interactions.
• Flexible and adaptable under multicultural environments.
• Negotiation Skills and effective problem solving/decision making skills.
• Highly developed leadership skills/expertise to assume the responsibilities of this position, including ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as ability to forecast major milestones.
Educational Background & Qualifications
• Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience or equivalent qualification for the tasks and has worked with many years of experience in Saudi Market). Advanced degree is considered an advantage
• Fluent in Arabic and English (verbal and written)
• 0-2 years of experience preferably has worked in the IVDs/Medical Devices Industry in Saudi Market.