Specialist, Regulatory & Site Activation

About This Opportunity

We are representing a confidential global clinical research organization seeking a Regulatory & Site Activation Specialist to join their team in India. This role serves as the local subject matter expert and primary point of contact for regulatory submissions, site activation, and maintenance activities across assigned clinical trial projects.

Our client is a mid-sized organization dedicated to advancing clinical research through innovative approaches and quality execution. This position offers the opportunity to work directly with clinical sites and cross-functional teams to ensure timely study start-up and regulatory compliance.

Responsibilities

• Support end-to-end site start-up processes from site identification through activation and ongoing maintenance, serving as the primary site contact
• Act as the internal point of contact at country level for regulatory and site activation activities in assigned studies
• Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents to comply with ICH GCP and country-specific requirements
• Review and provide guidance on country timelines for assigned studies
• Collect, receive, and perform initial review of required study-specific site regulatory and essential documents in accordance with SOPs and guidelines
• Track study-specific regulatory documents by site and country, following up with sites or internal team members as needed
• Proactively identify risks and generate mitigation strategies at country and site level
• Advise project teams about appropriate country regulatory strategies
• Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
• Provide timely updates on changing regulatory requirements and support interpretation of new regulations
• Maintain regulatory intelligence database for assigned countries
• Where required, provide local quality control of submission dossiers prior to dispatch

What We're Looking For

Required Qualifications:

• Four-year college degree with major concentration in medical, biological, physical, health, pharmacy, or other related sciences
• Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory-related functions
• Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations
• Fluency in local language with working knowledge of English
• Proficiency in MS Office applications including Word, Excel, and PowerPoint

Preferred Experience:

• Minimum 1 year of previous experience within the pharmaceutical or CRO industry
• Multilingual capabilities

Key Skills:

• Strong organizational and project management skills
• Excellent planning, strategizing, monitoring, and scheduling abilities
• Self-motivated approach to learning current regulatory processes and intelligence
• Excellent written and verbal communication skills
• Proactive problem-solving mindset
• Thorough understanding of country-level cultural norms and local healthcare systems
• Ability to adjust to changing environments and prioritize effectively
• Strong interpersonal skills in fast-paced, deadline-oriented environments
• Excellent multitasking abilities

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. For candidates who are a strong match, we will submit your profile to our client for consideration. Please do not contact the client directly, as all applications must be coordinated through our talent team to be considered.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Employment Opportunity: Get A Job.ai is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.