Regulatory And Start-Up

Fortrea

0-5 years

Not Disclosed

Bangalore, India

Openings: 10 June 3, 2026

Job Description

Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategies, Data Visualization, Machine Learning (ML), Master Da, Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi, Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines, Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Causality Assessment, Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory & Start-Up Specialist

Location: Bangalore
Category: Clinical
Job ID: 262931

Role Overview

The Regulatory & Start-Up Specialist is responsible for supporting clinical trial start-up activities, with a strong focus on contract management, site agreements, protocol amendments, and regulatory coordination. The role ensures timely execution of clinical trial agreements and supports smooth study initiation and maintenance in compliance with regulatory and quality standards.

Key Responsibilities

1. Clinical Trial Agreements (CTA) & Contract Management

Draft, review, negotiate, and finalize:
- Clinical Trial Agreements (CTAs)
- Confidentiality Agreements (CDAs)
- Amendments and related site contracts
Coordinate with sponsors, legal teams, clinical operations, and study teams for contract execution.
Ensure timely completion of contracts within study milestones and agreed timelines.
Track contract status in systems such as SAMS, UCV, and other tracking tools.
Identify risks, delays, and contract issues; escalate when necessary.

2. Site & Study Coordination

Maintain communication with study teams and sites regarding contract progress.
Ensure accurate documentation and filing of executed contracts.
Provide regular updates on contract status and outstanding issues.

3. Internal Approvals & Workflow Management

Facilitate internal approval processes for contract execution.
Ensure all required authorizations are obtained in a timely manner.
Maintain compliance with internal SOPs and workflows.

4. Protocol Amendments Support

Coordinate protocol amendment submissions and updates for assigned studies.
Review amendment requirements and communicate action items to relevant stakeholders.
Support contract and budget revisions based on protocol changes.
Track amendment timelines and ensure timely completion and implementation.

5. Cross-Functional Collaboration

Work closely with:
- Clinical Operations
- Regulatory Affairs
- Legal teams
- Finance teams
Ensure alignment and smooth execution of study start-up and amendments.

6. Documentation & System Management

Maintain accurate records in contract tracking systems.
Ensure proper upload and maintenance of amendment-related documents.
Track study metrics, reports, and status updates.

7. Risk Management & Escalation

Identify operational risks and delays impacting study timelines.
Escalate issues to management when required.
Provide proactive updates on potential risks and mitigation strategies.

8. Compliance & Quality

Ensure adherence to:
- SOPs (Standard Operating Procedures)
- ICH-GCP guidelines
- Sponsor requirements
- Quality standards
Support audit readiness through complete and accurate documentation.

9. Process Improvement

Participate in process improvement initiatives.
Contribute to enhancing efficiency in start-up and contract management processes.

10. Administrative & Operational Support

Maintain trackers, reports, and metrics.
Complete training, timesheets, and compliance requirements on time.
Support smooth operational execution of assigned studies.

Required Skills & Competencies

Strong understanding of clinical trial contracting processes
Knowledge of protocol amendments and clinical study start-up activities
Familiarity with ICH-GCP guidelines
Strong communication and negotiation skills
Stakeholder management ability
High attention to detail and accuracy
Strong organizational and multitasking skills
Ability to manage multiple studies under tight timelines
Proficiency in:
- Contract tracking systems
- Microsoft Office tools

Qualifications

Education

University/College degree in Life Sciences preferred
OR
Certification in allied health fields (e.g., Nursing, Medical Technology, Laboratory Technology)

Experience Requirements

3–5 years of experience in clinical research
Strong working knowledge of ICH-GCP and related regulatory guidelines
0–2 years of additional professional experience in related roles

Additional Expectations

Strong communication and organizational abilities
Ability to collaborate effectively in team environments
Consistent delivery of high-quality work
Strong computer and system proficiency

Work Environment

General office-based environment

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