Senior Country Approval Specialist

This is a fully remote position, open to applicants in Saudi Arabia.

📋 Description

• Oversee the preparation, review, and coordination of Country Submissions in accordance with the global submission strategy.

• Prepare, review, and coordinate local regulatory submissions to align with the global submission strategy.

• Provide regional regulatory strategy guidance to internal stakeholders.

• Develop and execute a local submission strategy.

• Offer technical expertise and coordination oversight for various projects.

• Act as the primary liaison for investigators and local regulatory authorities.

• Ensure adherence to guidelines and processes for effective communication within the internal team.

• Serve as the main contact at the country level for all activities related to submissions.

• Participate in Submission Team Meetings, Review Meetings, and Project Team meetings.

• Collaborate with internal functional departments to facilitate site start-up activities.

• Meet the company's target cycle times for site activations.

• Prepare regulatory compliance review packages.

• Coordinate with local SIA to ensure planned local submission activities.

• Develop country-specific Patient Information Sheet and Informed Consent form documents.

• Assist in negotiating grant budgets and payment schedules with sites.

• Identify and address local out-of-scope activities in contracts in a timely manner.

• Support the coordination of feasibility activities within agreed timelines.

• Ensure accurate maintenance of trial status information related to SIA activities.

• Oversee country study files to ensure compliance.

• Maintain knowledge of PPD SOPs and current regulatory guidelines.

• Direct and mentor assigned individuals.

• Proactively identify issues or anomalies within the regulatory process.

⛳️ Requirements

• Bachelor's degree or equivalent qualification.

• Prior experience that equips the candidate with the necessary knowledge, skills, and abilities to perform the role (equivalent to 3+ years).

• Strong understanding of SFDA and all relevant regional/national regulatory guidelines and EC regulations.

• Excellent oral and written communication skills.

• Strong interpersonal skills.

• Exceptional attention to detail and quality in documentation.

• Proficient negotiation skills.

• Good computer proficiency.

• Fluent in Arabic with good command of English language and grammar.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Ability to work effectively in both team settings and independently, with minimal supervision as necessary.

• Capability to mentor fellow SIA team members in a constructive and effective manner.

• A collaborative team player with strong team-building skills.

• Basic organizational and planning capabilities.

🏝️ Benefits

• Opportunities for professional development.