Regulatory Affairs Specialist - Saudi Arabia

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Regulatory Affairs Specialist – Saudi Arabia

An opportunity has arisen in Merck Ltd. Saudi Arabia, as Regulatory Affairs Specialist, reporting to Regulatory Affairs Managers, Saudi Arabia.

This role is responsible for the preparation, submission, follow-up, and approval of new product registrations, renewals, and ongoing maintenance activities. Also, develop and execute regulatory plans across KSA.

The candidate must adhere to the company regulatory standards while complying with local health authority regulations.

A strong network with local regulatory authorities is essential, with 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 product portfolio. Additionally, the Regulatory Affairs Specialist must collaborate closely with local commercial and functional teams to meet business and regulatory needs effectively.

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.
• 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.
• Identify & prioritize key areas of regulatory risk.
• 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
• 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 related to portfolio products.
• Prepare, review, and approve labeling and SOPs.
• Prepare labeling and artwork for Gulf as a support from the RHQ
• Prepare SOPs to reflect specific local requirements.
• Regulatory Affairs Specialist Job Qualifications :
• 3-5 years of regulatory or equivalent experience.
• Knowledge of local regulations & scientific knowledge.
• Fluent English and Arabic is a must.
• 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.
• 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.
  
  

Job Location is Riyadh, Saudi Arabia. Canadidate should be based in Saudi with the knowldge of RA & SFDA in Saudi. Holding Saudi Nationality.

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