Worldwide Clinical Trials is hiring for the position of Specialist, Regulatory & Site Activation in India. This is a full-time remote clinical research job focused on regulatory submissions, clinical trial site activation, essential document management and study start-up activities.
Candidates with a four-year degree in pharmacy, medical, biological, physical, health or another related science discipline and at least 2 years of clinical research experience may be eligible to apply.
The opportunity is particularly relevant for professionals with previous experience in clinical trial site activation, study start-up, regulatory affairs, site regulatory documentation or CRO operations who are looking for remote clinical research jobs in India.
Worldwide Clinical Trials Job Overview
Company: Worldwide Clinical Trials
Position: Specialist, Regulatory & Site Activation
Job Requisition ID: JR102867
Location: Virtual India
Work Mode: Remote
Employment Type: Full Time
Experience: Minimum 2 years in clinical research
Industry: Clinical Research / CRO
Department: Regulatory & Site Activation / Study Start-Up
Salary: Not disclosed by the employer
Application Mode: Online
About the Specialist, Regulatory & Site Activation Role
The Specialist, Regulatory & Site Activation serves as a subject matter expert and local point of contact for activities supporting regulatory submissions, clinical trial site activation and site maintenance.
The professional will help plan, initiate, review and track documents required for regulatory submissions and site activation while coordinating with sites, Regulatory Affairs Managers and project teams.
The role covers the clinical study start-up lifecycle from site identification through activation and maintenance, with significant responsibility for regulatory documentation, essential document collection, country requirements, ICH-GCP compliance and start-up timelines.
Key Responsibilities
Candidates selected for the Specialist, Regulatory & Site Activation position may be responsible for:
- Supporting end-to-end clinical trial site start-up from site identification through site activation and maintenance.
- Serving as the primary point of contact for assigned clinical research sites.
- Acting as the internal country-level contact for regulatory and site activation activities.
- Customizing country-specific Patient Information Sheets, Informed Consent Forms, labels and other local regulatory documents.
- Ensuring documentation complies with ICH-GCP and applicable country-specific regulatory requirements.
- Reviewing and advising project teams regarding country-specific study timelines.
- Communicating submission status, action plans and potential issues to the Regulatory Affairs Manager and relevant project team members.
- Collecting and conducting an initial review of study-specific regulatory and essential documents.
- Tracking regulatory documents at site and country level and following up with sites or internal stakeholders.
- Identifying potential regulatory or site activation risks and developing mitigation strategies.
- Advising project teams regarding appropriate country regulatory strategies.
- Maintaining communication with clinical research sites to support timely completion of study start-up and maintenance activities.
- Monitoring changes in regulatory requirements and providing relevant updates to project teams.
- Supporting interpretation of new clinical research regulations.
- Maintaining country-specific regulatory intelligence information.
- Performing local quality control of regulatory submission dossiers when required.
- Supporting translation review of submission documents, including applications, study synopses, ICFs and labels.
Qualification Requirements
Worldwide Clinical Trials requires candidates to have a minimum four-year college curriculum with a major concentration in:
- Pharmacy
- Medical Sciences
- Biological Sciences
- Physical Sciences
- Health Sciences
- Other related science disciplines
Accordingly, candidates with qualifications such as B.Pharm, Pharm.D, B.Sc or other relevant four-year life science/health science degrees may potentially qualify where their curriculum and experience meet the employer’s requirements.
Candidates with higher qualifications such as M.Pharm, M.Sc or other relevant postgraduate life science degrees may also be suitable when they meet the underlying educational and experience requirements.
Final eligibility is determined by Worldwide Clinical Trials based on the applicant’s complete academic and professional profile.
Experience Required
Applicants should have:
Minimum: 2 years of clinical research experience.
Experience specifically involving site activation and/or regulatory-related functions is preferred.
The employer also indicates a preference for candidates with at least 1 year of previous pharmaceutical or CRO industry experience.
This is therefore not primarily a fresher clinical research vacancy.
Regulatory & Clinical Research Knowledge
Candidates should have good knowledge of:
- ICH-GCP
- Clinical research conduct guidelines
- Country-specific clinical trial regulations
- Regulatory submissions
- Essential clinical trial documents
- Site activation processes
- Study start-up activities
- Regulatory document tracking
- Regulatory intelligence
- Submission dossier QC
Previous exposure to a CRO, pharmaceutical company, clinical research site or study start-up team can be particularly relevant.
Skills Required
Worldwide Clinical Trials is looking for professionals with strong organizational, planning and management capabilities.
Important competencies include planning, strategizing, monitoring, scheduling, regulatory intelligence, risk identification, problem solving and stakeholder communication.
Candidates should also possess excellent written and verbal communication skills and be capable of managing multiple activities in a fast-paced clinical research environment.
Proficiency in Microsoft Word, Excel and PowerPoint is required, while familiarity with contemporary digital systems is considered helpful.
Fluency in the local language and working knowledge of English are required, while multilingual candidates are preferred.
Why Consider This Clinical Research Opportunity?
The position provides an opportunity to work in a global CRO environment while developing expertise across multiple aspects of clinical trial start-up and regulatory operations.
Professionals can gain exposure to areas including:
Clinical Trial Start-Up: Supporting activities from site identification through activation.
Regulatory Submissions: Preparing, reviewing and tracking country and site-level regulatory documentation.
Site Management: Coordinating with investigators and site personnel to complete start-up and maintenance activities.
ICH-GCP Compliance: Ensuring documentation and processes align with applicable clinical research standards.
Regulatory Intelligence: Monitoring changing regulatory requirements and helping project teams interpret new regulations.
Risk Management: Identifying country- and site-level risks and developing mitigation strategies.
The employer also describes its workplace as collaborative and supportive, with an emphasis on professional development, inclusion and employee contribution to patient-focused clinical research.
Is This a Remote Job?
Yes. The job listing identifies the position as Remote with the location listed as Virtual India.
Candidates should nevertheless review the employer’s application page for any specific geographic, travel, home-office or employment-location requirements applicable to the role.
Who Should Apply?
This Worldwide Clinical Trials Regulatory & Site Activation job may be particularly suitable for professionals currently working as:
- Site Activation Specialist
- Study Start-Up Specialist
- Regulatory Affairs Specialist
- Regulatory Start-Up Associate
- Clinical Trial Associate
- Clinical Research Coordinator with regulatory experience
- Site Management Associate
- Regulatory Coordinator
- Clinical Research Associate with study start-up exposure
Applicants should carefully compare their experience against the official job requirements before submitting an application.
Salary for Specialist, Regulatory & Site Activation
Worldwide Clinical Trials has not disclosed a salary range in the supplied job posting.
For structured-data purposes, PharmaBharat estimates a potential market range of approximately ₹6,00,000–₹12,00,000 per year for a comparable specialist-level clinical research/regulatory position in India.
Important: This is an independent market estimate for informational purposes only. It is not an employer-published or guaranteed salary range. Actual compensation may differ significantly depending on experience, location, internal grading, skills and company policy.
How to Apply
