For our multinational client, we are seeking a motivated and independent Regulatory Affairs Specialist to lead RA activities in KSA. This role is responsible for the preparation, submission, follow-up, and approval of new product registrations, renewals, and ongoing maintenance activities. The Regulatory Affairs Specialist will also develop and execute regulatory plans across KSA.

To succeed as a Regulatory Affairs Specialist in this role, the candidate must adhere to the company’s regulatory standards while complying with local health authority regulations. A strong network with local regulatory authorities is essential, along with thorough knowledge of regulatory updates. The Regulatory Affairs Specialist will ensure clear communication with stakeholders regarding the impact of any new regulations and maintain compliance across the company’s product portfolio.

Additionally, the Regulatory Affairs Specialist must collaborate closely with local commercial and functional teams to meet business and regulatory needs effectively.

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

Regulatory Affairs Specialist – Job Responsibilities:

• Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for products, and communication of general regulatory requirements in support of licensing of the company’s products. Serves as a consultant to managers. 
• Manage regulatory activities relating to the 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 Regulatory Affairs Specialist 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– Job Qualifications:

• 3-5 years of regulatory or equivalent experience.
• Knowledge of local regulations & scientific knowledge.
• Fluent English and Arabic would be advantageous.
• 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 can 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’s team as a Regulatory Affairs Specialist in KSA. You’ll manage submissions, approvals, renewals, and regulatory strategies to ensure the company’s portfolio compliance. Apply now!

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