Country Approval Specialist (Senior) – Regulatory Submissions

About the role

Join a leading global CRO and support top pharmaceutical and biotech clients by managing country‑level regulatory submissions. You will work closely with internal teams and external investigators to ensure timely, compliant approvals across multiple jurisdictions.

Key responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, Ethics Committee, special applications such as gene‑therapy or viral‑safety dossiers) in line with the global strategy.
• Provide local regulatory strategy advice to internal stakeholders.
• Act as the primary country‑level contact for ethical and regulatory submission activities.
• Synchronise site start‑up activities with submission timelines to meet critical path targets.
• Collaborate with start‑up CRAs to assemble regulatory compliance packages.
• Develop country‑specific patient information sheets and informed consent documents.
• Assist with grant budget negotiations and feasibility coordination.
• Maintain accurate trial status data in PPD tracking systems and ensure proper study file management.

Required profile

• Bachelor’s degree or equivalent in a relevant field.
• Minimum 2 years of experience in regulatory affairs or clinical trial submissions.
• Strong knowledge of local regulatory requirements (MoH, Ethics Committee) and global SOPs.
• Excellent written and oral communication skills.

Required skills

• Regulatory submission preparation
• Regulatory strategy development
• Clinical trial regulatory processes

What we offer

• Opportunity to work on high‑impact global clinical programs.
• Collaborative environment with experienced regulatory professionals.
• Professional development and career progression within a leading CRO.