PHARMAFull-time
Specialist, Regulatory & Site Activation
By Admin · Regulatory Affairs
VIRTUAL INDIA (IN)REMOTEPOSTED: 9/2/2026
PHARMAFull-time
HIRING ORGANIZATIONWORLDWIDE CLINICAL TRIALSTechnology
ROLE DEFINITION & RESPONSIBILITIES
Job Overview
Full-time remote position supporting regulatory submissions, clinical trial site activation and site maintenance activities in India.
Serves as a subject matter expert and local point of contact for regulatory and site start-up activities for assigned awarded projects.
Responsible for planning, initiating, tracking and coordinating documents required for regulatory submissions.
Supports collection, review and management of essential documents required for country-level and site-level regulatory requirements.
Communicates start-up status, risks, mitigation plans and required actions to relevant project stakeholders.
Supports achievement of study site activation goals from site identification through activation and maintenance.
End-to-End Site Start-Up & Activation
Support end-to-end clinical trial site start-up activities from site identification through site activation and maintenance.
Serve as the primary point of contact for assigned clinical trial sites during start-up and maintenance activities.
Maintain regular communication with sites to ensure timely completion of site activation requirements.
Coordinate and monitor site-level activities required to achieve activation timelines.
Track outstanding start-up actions and follow up with sites or internal team members as required.
Support ongoing site maintenance activities when applicable.
Regulatory Affairs & Country-Level Responsibilities
Act as the internal primary point of contact at the country level for regulatory and site activation activities for assigned studies.
Plan, initiate and track regulatory submission activities.
Collect and manage documents required for regulatory submissions.
Provide country-level regulatory requirements and guidance to support study start-up.
Review country-specific timelines for assigned clinical studies and provide advice to relevant stakeholders.
Advise the Regulatory Affairs Manager and project team regarding appropriate country-level regulatory strategies.
Communicate changing regulatory requirements and provide support with interpretation of new regulations.
Maintain regulatory intelligence information and databases for the assigned country.
Remain informed about current regulatory processes and country-specific regulatory intelligence.
Essential Document Collection & Review
Collect and receive required study-specific site regulatory and essential documents.
Perform first-level review of regulatory and essential documents.
Conduct document review according to applicable Standard Operating Procedures, guidelines and study-specific plans.
Track regulatory and essential documents by site and/or country.
Follow up with sites and internal project team members regarding missing, incomplete or outstanding documentation.
Report document status and progress to the Regulatory Affairs Manager.
Support timely completion of documentation required for regulatory submissions and site activation.
Informed Consent & Local Document Customization
Customize country-specific Patient Information Sheets.
Customize Informed Consent Forms to meet country-specific requirements.
Support preparation and customization of clinical trial labels.
Customize local regulatory documents where required.
Ensure localized documents comply with ICH-GCP requirements.
Ensure country-specific documentation meets applicable local regulatory requirements.
Support review of translation requirements for regulatory and clinical trial submission documents.
Regulatory Submission Quality Control
Provide local quality control of regulatory submission dossiers where required before dispatch.
Review submission documentation for completeness and readiness.
Support quality and compliance of country-level submission packages.
May act as a contact point for translation review of submission documents.
Support review of translated applications, study synopses, Informed Consent Forms, labels and other submission documents.
Help ensure submission documents are suitable for local regulatory requirements.
Risk Management & Project Communication
Proactively identify regulatory and site activation risks at country and site levels.
Develop and support mitigation strategies for identified risks.
Communicate submission status, risks and action plans to the Regulatory Affairs Manager.
Provide timely updates to relevant project team members.
Monitor progress against planned country and site start-up timelines.
Identify potential process issues and anticipate practical solutions.
Support project teams in maintaining quality while meeting regulatory and activation timelines.
Compliance & Regulatory Standards
Maintain familiarity with and comply with company Standard Operating Procedures.
Apply ICH-GCP requirements to regulatory and site activation activities.
Follow applicable country-level regulations.
Maintain knowledge of relevant clinical research conduct guidance.
Support compliant collection, review and submission of regulatory and essential documentation.
Maintain awareness of changing local regulatory requirements and regulatory intelligence.
Stakeholder & Site Relationship Management
Build and maintain professional relationships with local investigators.
Develop working relationships with key clinical site personnel.
Maintain awareness of country-level cultural norms relevant to clinical research operations.
Understand local healthcare systems and their relevance to site activation.
Communicate clearly with internal project teams and external site stakeholders.
Seek and provide guidance within a collaborative team environment.
Organizational & Project Management Skills
Manage multiple regulatory and site activation tasks simultaneously.
Plan, strategize, manage, monitor and schedule assigned activities.
Review and critique processes and progress where necessary.
Prioritize activities effectively in a fast-paced and deadline-oriented environment.
Balance detailed operational tasks with broader strategic responsibilities.
Adapt to changing priorities while maintaining delivery timelines and quality standards.
Demonstrate strong organizational and management skills.
Work proactively and independently while collaborating with the broader project team.
Technical & Digital Skills
Proficiency in Microsoft Word.
Proficiency in Microsoft Excel.
Proficiency in Microsoft PowerPoint.
Ability to use contemporary digital systems.
Aptitude for digital and technology-based systems supporting regulatory and site activation activities.
Qualifications & Experience
Minimum four-year college curriculum with a major concentration in Medical Sciences, Biological Sciences, Physical Sciences, Health Sciences, Pharmacy or another related scientific discipline.
Minimum two years of experience in clinical research.
Clinical research experience in site activation and/or regulatory-related functions is preferred.
Preferred minimum one year of experience within the pharmaceutical or Contract Research Organization industry.
Good knowledge of ICH-GCP.
Knowledge of relevant clinical research conduct guidance.
Knowledge of applicable country regulations.
Fluent communication ability in the local language.
Working knowledge of English.
Multilingual ability is preferred.
Performance & Career Progression
Advancement to the next level is not automatic based solely on years of experience.
Career progression is based on demonstrated competency.
Progression depends on increasing levels of responsibility.
Ability to work independently is an important consideration for advancement.
Professional growth is linked to proven performance and capability.
Company & Career Environment
Worldwide Clinical Trials is a global midsize Contract Research Organization with more than 3,500 professionals.
The organization emphasizes innovation, quality and excellence in supporting clinical research and drug development.
Employees contribute to clinical research activities intended to improve outcomes for patients and caregivers.
The company promotes accessible leadership and cohesive, supportive teams.
Worldwide emphasizes a diverse and inclusive workplace designed to support collaboration, creativity and professional success.
The organization promotes an environment where professionals can contribute their expertise and develop their careers while supporting clinical development programs.
REQUIRED VERIFIED SKILLS
Clinical Research
Site Activation
Clinical Trial Start-Up
Regulatory Affairs
Regulatory Submissions
Country-Level Regulatory Requirements
Site Regulatory Document Management
Essential Document Collection
Essential Document Review
ICH-GCP
Clinical Research Regulations
Country Regulations
Informed Consent Form Management
Patient Information Sheet Customization
Regulatory Document Customization
Submission Dossier Review
Regulatory Submission Quality Control
Site Tracking
Regulatory Document Tracking
Regulatory Intelligence
Risk Identification
Risk Mitigation
Site Communication
Regulatory Strategy
Site Maintenance
Clinical Trial Operations
SOP Compliance
Project Coordination
Timeline Management
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
English Communication
Local Language Communication
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range or compensation figures are disclosed in the official job posting. Compensation for this India-based remote role may depend on the candidate's clinical research experience, site activation and regulatory expertise, educational qualifications and Worldwide Clinical Trials' internal compensation structure. Candidates should discuss fixed compensation, performance-related incentives where applicable, remote-work support, insurance, leave benefits, professional development opportunities and other employment benefits during the recruitment process. Experience in regulatory submissions, site start-up and CRO or pharmaceutical industry operations may strengthen a candidate's compensation positioning.
ORGANIZATION CONTEXT & CULTURE
Worldwide Clinical Trials is actively hiring for this position.
INDUSTRY: Technology
EXPECTED CAREER ROADMAP
This Specialist, Regulatory & Site Activation role provides a strong career pathway within clinical trial start-up, regulatory affairs and clinical operations. Experience gained in country-level regulatory strategy, regulatory submissions, essential document management, ICH-GCP compliance and end-to-end site activation can support progression into Senior Specialist, Regulatory Affairs Manager, Country Start-Up Lead, Clinical Trial Start-Up Manager or broader Clinical Operations leadership roles. Developing expertise in local regulatory intelligence, submission dossier quality control, country-specific consent documentation and site relationship management can also create opportunities in global regulatory operations and international clinical trial management. Worldwide Clinical Trials explicitly evaluates progression based on demonstrated competency, level of responsibility and ability to work independently rather than automatically promoting employees solely based on years of experience.
APPLICATION ADVISORY
Highlight your clinical research experience and clearly quantify your experience in site activation, clinical trial start-up and regulatory activities. Emphasize practical exposure to regulatory document collection, essential document review, country-level requirements, site communication and submission tracking. Demonstrate knowledge of ICH-GCP and applicable Indian clinical research regulations. Include experience working with Informed Consent Forms, Patient Information Sheets, regulatory submissions or Trial Master File documentation where applicable. Prepare specific interview examples showing how you managed missing documents, identified regulatory risks, followed up with clinical sites and maintained start-up timelines. Demonstrate strong organizational skills by explaining how you prioritize multiple studies and deadlines. Candidates should also be prepared to discuss their ability to work independently in a remote environment, collaborate with country and global project teams and communicate effectively with investigators and site personnel.
RECOMMENDED TRAINING
1/5
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