Regulatory Specialist, Site Activation

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

📋 Description

• Facilitate the complete site start-up process from site selection to activation and ongoing maintenance, acting as the main point of contact for sites.

• Serve as the primary internal contact for regulatory and site activation efforts at the country level.

• Tailor country-specific patient information sheets, informed consent documents, labels, and local regulatory paperwork to meet ICH GCP and national standards.

• Evaluate and provide insights on country timelines for the studies assigned.

• Relay submission statuses and action plans to the Regulatory Affairs Manager and the project team.

• Collect, receive, and conduct initial reviews of study-specific site regulatory and essential documentation.

• Monitor regulatory documents by site or country, follow up as necessary, and report findings to the Regulatory Affairs Manager.

• Identify risks at the country or site level and develop strategies for mitigation.

• Advise the Regulatory Affairs Manager and project team regarding country-specific regulatory strategies.

• Maintain communication with sites to ensure prompt completion of start-up and maintenance tasks.

• Provide updates on evolving regulatory requirements and assist in interpreting new regulations.

• Keep the regulatory intelligence database updated for the assigned country.

• Adhere to SOPs, ICH GCP, and relevant regulations.

• Conduct local quality control of submission dossiers prior to dispatch when necessary.

• Act as a point of contact for the review of translations of submission documents when needed.

• Perform additional tasks as assigned.

⛳️ Requirements

• A minimum of a four-year degree with a major focus in medical, biological, physical, health, pharmacy, or related sciences.

• At least two years of experience in clinical research, ideally in site activation and/or regulatory functions.

• Preferred minimum of one year of prior experience in the pharmaceutical/CRO sector.

• Solid understanding of ICH GCP, relevant clinical research guidance, and national regulations.

• Multilingual capabilities preferred; fluency in the local language and a working knowledge of English.

• Strong organizational and management competencies.

• Excellent skills in planning, strategizing, managing, monitoring, scheduling, and evaluating.

• Outstanding written and verbal communication abilities.

• Proactive in identifying issues and anticipating solutions.

• Comprehensive understanding of country-specific cultural norms and local healthcare systems.

• Capacity to establish and nurture relationships with local investigators and key site personnel.

• Ability to adapt to a dynamic environment and prioritize detailed and strategic tasks while ensuring timely and quality delivery.

• Team-oriented approach to work.

• Strong interpersonal skills in a fast-paced, deadline-driven, and evolving environment.

• Capability to manage multiple tasks effectively.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Familiarity with contemporary digital systems is advantageous.

🏝️ Benefits

• Equal employment opportunities.

• A diverse and inclusive workplace.

• A collaborative and creativity-driven environment.

• Supportive teams and approachable leadership.

• Opportunities for professionals from all backgrounds and experiences to thrive.