Parexel Hiring Regulatory Affairs Associate
Are you looking for a remote Regulatory Affairs Job in India? Parexel is hiring a Senior Regulatory Affairs Associate to support end-to-end Clinical Trial Application submissions across the European Union Clinical Trials Regulation and Rest of the World regions.
The position will function as a Clinical Trial Submission Lead, responsible for planning, coordinating, and executing global regulatory submissions. Candidates with experience in EU CTR, ROW CTA submissions, regulatory documentation, and global project management are encouraged to apply.
- Job Title: Senior Regulatory Affairs Associate
- Functional Role: Clinical Trial Submission Lead
- Company: Parexel
- Primary Location: India
- Work Arrangement: Remote
- Qualification: Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline
- Experience: Minimum five years
- Required Expertise: EU CTR and ROW Clinical Trial Application submissions
About Parexel
Parexel is a global clinical research organization that helps pharmaceutical, biotechnology, and medical-device companies navigate the drug-development and regulatory landscape.
As part of Parexel Consulting, professionals work closely with clients to develop and implement regulatory strategies designed to advance products toward the market and maintain regulatory compliance throughout their lifecycle.
The organization provides exposure to different product types, therapeutic areas, global markets, and challenging regulatory assignments. Employees can collaborate with experienced regulatory professionals while developing their skills through mentorship and continuous learning.
Job Description
The Clinical Trial Submission Lead is responsible for the end-to-end planning, coordination, and execution of Clinical Trial Applications across EU CTR and Rest of the World regions.
The Parexel Regulatory Affairs Job requires strong regulatory expertise, effective cross-functional collaboration, and proactive risk management to deliver accurate, compliant, and timely submissions across multiple studies and countries.
The selected candidate will manage project timelines, regulatory documentation, submission dependencies, quality requirements, and relationships with internal and external stakeholders.
Key Responsibilities
- Lead end-to-end Clinical Trial Application project management across multiple studies.
- Coordinate regulatory submissions across multiple countries.
- Plan, track, and deliver applications according to established timelines.
- Ensure submissions comply with applicable regulatory requirements.
- Apply detailed knowledge of EU CTR requirements.
- Support Clinical Trial Application submissions across Rest of the World regions.
- Manage risks, issues, dependencies, and complexities associated with global regulatory environments.
- Oversee core clinical and regulatory documentation.
- Coordinate activities with cross-functional global teams.
- Build and maintain strong stakeholder relationships.
- Resolve conflicts and address project-related concerns.
- Monitor key performance indicators associated with submission timelines.
- Track the quality and completeness of regulatory deliverables.
- Identify potential submission and compliance risks.
- Lead quality investigations when required.
- Support timely, accurate, and compliant regulatory submissions.
Eligibility Criteria
- Educational Qualification: Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Experience: Minimum five years of relevant industry experience.
- Preferred Industries: Pharmaceutical, CRO, medical-device, or a similar regulated industry.
- Required Experience: Clinical Trial Application submissions across EU CTR and ROW regions.
- Work Arrangement: Remote within India.
Required Regulatory Expertise
- Practical knowledge of the European Union Clinical Trials Regulation.
- Experience with global and Rest of the World regulatory submissions.
- Understanding of Clinical Trial Application processes.
- Familiarity with clinical trials and applicable regulatory procedures.
- Experience managing core clinical and regulatory documents.
- Ability to interpret and apply country-specific regulatory requirements.
- Understanding of submission planning, tracking, and execution.
- Experience monitoring regulatory timelines, quality standards, and deliverables.
Required Skills
- Strong project-management and execution abilities.
- Experience working in a global or matrix environment.
- Regulatory strategy and submission-management skills.
- Risk identification and issue-management abilities.
- Strong stakeholder-engagement and relationship-building skills.
- Excellent written and verbal communication.
- Strong analytical and problem-solving abilities.
- Ability to resolve conflicts constructively.
- Excellent attention to detail.
- Strategic and results-driven approach.
- Adaptability and resilience.
- Ability to collaborate effectively with global teams.
- Capacity to manage multiple studies, countries, and deadlines simultaneously.
Success Profile
Candidates are likely to succeed in this role if they are:
- Effective communicators
- Detail-oriented professionals
- Strategic problem-solvers
- Strong relationship-builders
- Results-driven team members
- Adaptable and collaborative regulatory professionals
Why Join Parexel?
Parexel offers regulatory professionals the opportunity to work with a diverse portfolio of biopharmaceutical and medical-device clients. Employees can gain exposure to different therapeutic areas, product types, countries, and regulatory pathways.
The remote work arrangement offers flexibility while allowing professionals to remain connected to an experienced and supportive global team. Employees can also strengthen their regulatory expertise through challenging assignments, collaboration, mentorship, and continuous learning.
Apply for the Parexel Regulatory Affairs Job
This Parexel Regulatory Affairs Job is an excellent opportunity for experienced Life Sciences and Pharmacy professionals seeking a remote regulatory career in India.
Candidates with at least five years of pharmaceutical or CRO experience and proven expertise in EU CTR, ROW CTA submissions, global project management, and regulatory processes are encouraged to apply.
Pharmanika is a career information portal. Candidates should verify the qualifications, experience requirements, remote-work eligibility, application deadline, and other details through the official Parexel job notification before applying.
