Parexel, a global leader in clinical research and regulatory consulting, is hiring Regulatory Affairs Associates in Bengaluru, India. This opportunity is ideal for professionals with 2โ5 years of experience in Regulatory Affairs (CMC) who want to contribute to global regulatory submissions and lifecycle management activities.
Parexel plays a critical role in advancing healthcare innovation by supporting pharmaceutical and biotech companies through clinical trials, regulatory strategy, and market access solutions. As a Regulatory Affairs Associate, you will work on regulatory frameworks, submission strategies, and CMC documentation across multiple regions.
Professionals experienced in CTD guidelines, EU regulatory submissions, and lifecycle management will find this role an excellent opportunity to grow in global regulatory affairs.
Job Details
- Position: Regulatory Affairs Associate
- Company: Parexel
- Location: Bengaluru / Remote (India)
- Job Type: Full-time
- Experience: 2โ5 Years
- Department: Regulatory Affairs โ CMC
- Shift: EU Shift
Key Responsibilities
The Regulatory Affairs Associate will support regulatory strategy and submission activities related to pharmaceutical products.
Key responsibilities include:
- Understand global regulatory frameworks and regional regulatory trends.
- Provide regulatory input on CMC documentation requirements.
- Develop and execute submission delivery strategies.
- Review regulatory documents and ensure compliance with health authority guidelines.
- Analyze regulatory procedures and special designations used during development and marketing authorization.
- Collaborate with cross-functional teams including regulatory, medical, and marketing teams.
- Develop and maintain submission delivery plans and content plans.
- Author regulatory dossier sections related to changes in approved MAA.
- Conduct change evaluations according to country-specific guidelines.
- Manage lifecycle regulatory activities for EU markets.
- Review and submit dossiers to regulatory authorities.
- Support negotiations with Health Authorities (HA) during approvals.
Eligibility Criteria
Candidates applying for the Parexel Regulatory Affairs Associate role should meet the following criteria:
Education
- B.Pharm / M.Pharm / Pharm.D / Life Sciences or related discipline
Experience
- 2 to 5 years of experience in Regulatory Affairs โ CMC
Skills & Knowledge
- Strong understanding of CTD (Common Technical Document) guidelines
- Experience with EU regulatory submissions and lifecycle management
- Knowledge of CMC documentation and regulatory procedures
- Ability to review regulatory dossiers and manage submission activities
- Excellent communication and cross-functional collaboration skills
Why Join Parexel?
Working at Parexel offers a unique opportunity to contribute to global healthcare development.
Benefits
- Opportunity to work on global regulatory submissions
- Exposure to EU regulatory frameworks
- Work with leading biopharma and life sciences companies
- Career growth in Regulatory Affairs and Clinical Development
- Collaborative global work environment
- Competitive salary and benefits package
How to Apply
