Senior Country Approval Specialist / Principal Ctry Approval Specialist

This role will lead operational priorities where safety, quality, compliance, and execution discipline are central to success. You will collaborate with field leadership, support functions, and cross-functional stakeholders to improve accountability, service delivery, and operational consistency. The position offers the opportunity to influence operational scale, customer outcomes, and organizational performance within a life sciences environment.

Responsibilities

• Prepare and coordinate local regulatory submissions according to the global strategy
• Advise on local regulatory strategy for internal clients
• Develop and implement local submission strategies
• Act as the primary contact for investigators and local regulatory authorities
• Ensure effective internal and external communications for submission processes
• Oversee study files to meet compliance standards
• Identify and address issues within the regulatory submission process

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 5-8 years of relevant experience in regulatory submissions
• Strong knowledge of regional/national regulatory guidelines and EC regulations
• Effective communication and interpersonal skills
• Attention to detail and strong documentation abilities

Pay

$110,000 – $130,000 annually

Schedule

Standard Monday to Friday work schedule

Benefits

• Office-based work environment
• Opportunities for mentorship and skill development
• Access to personal protective equipment during work
• Participation in team meetings to foster collaboration