Parexel Hiring Senior Regulatory Affairs Associate – EU/US CMC & Lifecycle Management
- Parexel Hiring Senior Regulatory Affairs Associate – EU/US CMC & Lifecycle Management | 4–8 Years | Bengaluru / Remote India
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Required Skills
- Location & Work Model
- Application Process
- Frequently Asked Questions (FAQs)
- 1. What experience is required for this role?
- 2. Is EU regulatory experience mandatory?
- 3. Is remote work available?
- 4. Is CMC experience required?
- 5. What career growth opportunities exist?
- Recruitment Summary
Parexel Hiring Senior Regulatory Affairs Associate – EU/US CMC & Lifecycle Management | 4–8 Years | Bengaluru / Remote India
Parexel is hiring a Senior Regulatory Affairs Associate for its Consulting division, based in Bengaluru with remote flexibility across India. This full-time opportunity is ideal for regulatory professionals with 4–8 years of experience in pre-approval and post-approval lifecycle management of drug products, including small molecules and biologics.
The role focuses on global regulatory strategy, CMC documentation, Marketing Authorization Applications (MAA), variations management, and health authority interactions across EU, US, and other international markets. If you have hands-on experience in regulatory submissions, CMC compliance, and EU procedures such as DCP, MRP, and National routes, this is a strong opportunity to advance within a global regulatory consulting environment.
Company Overview
Parexel is a global clinical research organization and regulatory consulting partner serving biopharmaceutical and medical device companies worldwide. The company supports drug development programs from early clinical stages through post-marketing lifecycle management.
Parexel Consulting specializes in regulatory strategy, submission planning, CMC advisory, and global market access support. By partnering with innovative biotech and established pharmaceutical companies, Parexel plays a critical role in accelerating regulatory approvals while ensuring compliance with global health authority requirements.
Working at Parexel means exposure to diverse therapeutic areas, complex regulatory pathways, and collaboration with cross-functional global teams. The organization emphasizes continuous learning, mentorship, and strategic problem-solving in regulatory science.
Job Role & Responsibilities
The Senior Regulatory Affairs Associate supports regulatory strategy development and execution for global and regional submissions, with strong emphasis on CMC compliance and lifecycle management.
Key Responsibilities
- Manage pre-approval and post-approval regulatory lifecycle activities for small molecules and biologics.
- Prepare, review, and submit Marketing Authorization Applications (MAA) and variations for EU markets through DCP, MRP, and National procedures.
- Author and deliver regulatory maintenance submissions from global or regional perspectives.
- Prepare documentation for super-grouping, grouping, and work-sharing variation procedures.
- Review DMFs, batch records, product specifications, and stability data to ensure regulatory compliance.
- Provide regulatory impact assessments for change proposals and identify required documentation for submissions.
- Handle CMC-related health authority queries and prepare responses.
- Prepare and submit safety variations and post-approval CMC updates.
- Execute submission delivery plans and maintain submission content strategies.
- Work with Regulatory Information Management Systems such as Veeva Vault.
- Collaborate with cross-functional stakeholders across regulatory, quality, and CMC teams.
This role requires deep understanding of global pharmaceutical legislation, ICH guidelines, and regulatory CMC requirements across major markets.
Eligibility / Qualifications
Educational Qualification
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related scientific discipline.
Relevant Courses: B.Pharm, M.Pharm, Pharm.D, MSc Chemistry, MSc Organic Chemistry, MSc Analytical Chemistry, MSc Life Sciences, Biotechnology, Regulatory Affairs, Pharmaceutical Chemistry, Industrial Pharmacy.
Experience
- 4–8 years of experience in regulatory affairs within pharmaceutical, biotech, or CRO environments.
- Experience in EU and US regulatory procedures, including post-approval lifecycle management.
- Hands-on experience with CMC documentation and health authority queries.
Required Skills
- Strong understanding of ICH guidelines and global pharmaceutical legislation.
- Experience with EU procedures such as DCP, MRP, and National filings.
- Knowledge of regulatory frameworks for small and large molecules.
- Familiarity with Veeva Vault or similar Regulatory Information Management Systems.
- Strong analytical, organizational, and communication skills.
- Ability to mentor junior team members and work independently in a consulting environment.
Professionals with exposure to global submissions across multiple regions (EU, US, ROW markets) will have an advantage.
Location & Work Model
Primary Location: Bengaluru, India
Additional Location: Remote (India)
Department: Regulatory Consulting
Application Process
Interested candidates can apply directly through the official Parexel careers portal using the link below:
Apply Here:
https://jobs.parexel.com/en/job/-/-/877/92332710624
Applicants should highlight experience in EU/US submissions, CMC regulatory activities, variation management, and lifecycle maintenance in their resumes.
Frequently Asked Questions (FAQs)
1. What experience is required for this role?
A minimum of 4–8 years of regulatory affairs experience in pharmaceutical or biotech environments is required.
2. Is EU regulatory experience mandatory?
Yes. Working knowledge of EU procedures such as DCP, MRP, and post-approval requirements is essential.
3. Is remote work available?
Yes. The role offers flexibility with remote work options within India.
4. Is CMC experience required?
Yes. Hands-on experience handling CMC documentation and health authority queries is required.
5. What career growth opportunities exist?
Professionals can progress to Regulatory Affairs Manager, Global Regulatory Lead, or Strategic Regulatory Consultant roles.
Recruitment Summary
| Company | Parexel |
|---|---|
| Vacancies | Senior Regulatory Affairs Associate |
| Required Education | Bachelor’s/Master’s in Pharmacy, Life Sciences, Chemistry or Related Field |
| Experience | 4–8 Years in Regulatory Affairs & CMC Lifecycle Management |
To apply for this job please visit jobs.parexel.com.
