Regulatory Affairs Job at Worldwide Clinical Trials | Apply Now
Looking for a regulatory affairs job in India with global exposure? Worldwide Clinical Trials is hiring a Regulatory Affairs Manager (Contractor – Remote) for its Virtual India team. This full-time remote role offers experienced professionals the opportunity to lead regulatory submissions, manage cross-regional approvals, and contribute to innovative clinical research projects. If you are seeking remote jobs in the pharmaceutical and clinical research industry, this could be the ideal career move.
Job Details:
- Job Position: Regulatory Affairs Manager – Contractor (Remote)
- Location: Virtual India (Remote)
- Job ID: JR101759
About the Company:
Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. Their mission is to work with passion and purpose every day to improve lives and they are looking for others who value this same pursuit. They believe everyone plays an important role in making a world of difference for patients and their caregivers. The company prioritizes cultivating a diverse and inclusive environment that promotes collaboration and creativity.
Job Description:
The Regulatory Affairs department plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. The Regulatory Affairs Manager will:
- Review study budgets and costing about contract negotiation
- Prepare regulatory sections of proposals and feasibility reports
- Coordinate and manage regulatory and ethics committee submissions
- Maintain approvals throughout EMEA, Asia Pacific, and Latin America
- Ensure accurate compilation, management, and tracking of submissions
- Provide expert regulatory advice and contribute to regulatory project work
- Communicate submission status with Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff
- Contribute to preparation of technical documentation such as IMPDs and IBs
- Review documentation to ensure compliance with ICH GCP and country-specific requirements
Qualifications:
- Minimum four-year college degree with a major concentration in medical, health or related field
Experience Required:
- Minimum 5 years within the pharmaceutical/CRO industry
- Demonstrated senior-level regulatory or clinical start-up experience across the APAC region
- Proficient in cross-cultural communication
- Proficient in spoken and written English
- Proven leadership and organizational management skills
Key Responsibilities:
- Lead and manage regulatory submissions across APAC, EMEA, and Latin America
- Ensure compliance with ICH GCP and country-specific regulatory requirements
- Support business development through regulatory expertise
- Maintain communication with sponsors and internal stakeholders
- Mentor and guide junior regulatory professionals
- Support contract negotiation and proposal development
