For our multinational client, we are looking for a motivated and well-spoken Regulatory Affairs Specialist leading the KSA country. The role is responsible for RA preparation, submission, follow-up, and approval of new registrations, renewals, and maintenance activities, as well as setting RA plans and executing them across KSA.

To be successful in this role, the candidate needs to comply with the company’s RA standards under the umbrella of the local health authority regulations, should have a very strong network with local RA authorities, be very well-oriented with all RA updates and regulations, and communicate with the relevant stakeholders the impact of any recent updates and make sure the company’s portfolio complies with these regulations.

The candidate should be skilled to handle local commercial & function needs & work hand in hand with  latter teams.

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within 5 working days at the earliest. If you don’t hear from us, please consider your application unsuccessful.

Regulatory Affairs Specialist – Responsibilities:

• Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for products, and communicating general regulatory requirements in support of licensing of the company’s products. Serves as a consultant to managers. 
• Manage regulatory activities relating to a specific global portfolio of products/projects.
• Responsible for the local implementation of complex global regulatory strategies.
• Obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of the company’s products. 
• Serves as a consultant to managers. Manage regulatory activities relating to a specific portfolio of products/projects.
• Understands all aspects and phases of role-based activities (e.g.: the submission process across the product lifecycle continuum, including management of submission content/format to ensure high-quality submissions that facilitate review/approval by Regulatory Authorities.  Ownership/Life cycle of Regulatory systems, trackers, and databases.  Stewardship of the company’s position/impact of new/changing regulations, guidance, and standards.)
• Initiate and develop complex regulatory project plans.
• Identify & prioritize key areas of regulatory risk.
• Initiate and develop role-based complex regulatory activities.
• Monitor applicable regulatory requirements.
• Create and maintain regulatory files in a format consistent with requirements.
• Provide regulatory advice to project teams.
• Respond to complex questions from regulatory authorities within strict timelines
• Provide role-based regulatory advice to project teams.
• Coordinate responses to complex questions from cross-functional areas in a timely manner
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
• Maintain and update existing regulatory authorizations.
• Manage regulatory activities relating to a specific portfolio of products/projects.
• Prepare, review, and approve labeling and SOP’s. 
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations.
• Prepare SOPs to reflect specific local requirements.
• Responsible for the update and maintenance of role-based activities.
• Lead or represent Regulatory Affairs in project teams.
• Provide guidance and coaching for areas of responsibility to lower-level team members.

Regulatory Affairs Specialist – Qualifications & Requirements:

• 5 years of regulatory or equivalent experience within a pharmaceutical.
• Knowledge of local regulations & scientific knowledge.
• Fluent Arabic & English.
• Bachelor’s degree or country equivalent in a scientific discipline.
• Project management skills.
• Manage multiple projects and deadlines.
• Ability to multitask and prioritize.
• Interpersonal and communication skills with strong negotiation skills.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research).
• Ability to work effectively in multinational & multicultural environments.
• Ability to identify compliance risks and escalate when necessary.
• Stress resistance.
• Ability to provide regular weekly updates on progress and explain the progress.
• Strong team player, with a flexible approach yet able to work unsupervised and under pressure.
• Self-motivated with a high level of initiative
• Excellent communication skills and be able to work in a rapid-response environment.

Join our client in medical devices as a Regulatory Affairs Specialist in KSA, leading regulatory activities and ensuring compliance with local health authority regulations. Apply now!

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