Parexel Work from home Hiring Regulatory Affairs Consultant
- Parexel Hiring Regulatory Affairs Consultant (Remote) | Senior Pharma Regulatory Strategy Role
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Background:
- Experience Required:
- Skills Required:
- Location & Salary
- Application Process
- Why This Role Matters in Healthcare
- Frequently Asked Questions (FAQs)
- 1. Is this role suitable for freshers?
- 2. What type of products will I work on?
- 3. What submissions are involved in this role?
- 4. Is this a remote job?
- Summary
Parexel Hiring Regulatory Affairs Consultant (Remote) | Senior Pharma Regulatory Strategy Role
Looking to step into a high-impact regulatory affairs consulting role? Parexel is hiring experienced professionals for the position of Regulatory Affairs Consultant in a remote setup across India. This opportunity is designed for senior-level candidates with 7–10 years of experience in global regulatory affairs, lifecycle management, and CMC submissions.
This role offers direct exposure to global markets including the US, EU, Japan, Canada, Switzerland, and Australia, making it a premium career opportunity in regulatory strategy, drug development consulting, and global submissions.
Company Overview
Parexel is a leading global clinical research organization (CRO) and consulting firm that supports biopharmaceutical and medical device companies in navigating complex regulatory environments. With decades of industry experience, Parexel is known for delivering regulatory consulting, clinical development, and market access solutions.
The company partners with global clients to accelerate product approvals and ensure compliance across multiple regulatory jurisdictions, making it a trusted name in regulatory affairs and clinical research consulting.
Job Role & Responsibilities
As a Regulatory Affairs Consultant, you will lead and support global regulatory strategy, submission planning, and lifecycle management activities.
Key Responsibilities:
- Manage lifecycle activities for approved and marketed drug products including biologics and vaccines
- Develop and implement regulatory strategies for global submissions
- Prepare, review, and deliver regulatory documents including IND, NDA, BLA, MAA, DMF, and IMPD
- Handle CMC-related submissions and respond to health authority queries
- Author and review variations, renewals, site transfers, and annual reports
- Conduct regulatory gap analysis and provide remediation strategies
- Work on EU procedures including DCP, MRP, and National filings
- Coordinate with cross-functional teams and stakeholders for submission readiness
- Evaluate change controls and deviations and define regulatory impact
- Maintain updated knowledge of global regulatory guidelines and compliance requirements
- Utilize regulatory systems such as Veeva Vault and RIMS tools
- Mentor junior team members and guide project execution
Eligibility / Qualifications
Educational Background:
B.Pharmacy, M.Pharmacy, Pharm.D, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Advanced Degree (PhD preferred)
Experience Required:
- 7–10 years of experience in regulatory affairs or regulatory consulting
- Experience in lifecycle management of biologics, vaccines, and pharmaceutical products
- Strong exposure to US, EU, and global regulatory frameworks
- Experience in CMC documentation and submissions
Skills Required:
- Strong knowledge of global regulatory guidelines and submission processes
- Expertise in regulatory strategy development and execution
- Excellent communication and stakeholder management skills
- Ability to work independently in a remote environment
- Strong analytical and problem-solving capabilities
Location & Salary
- Location: Remote (India)
- Job Type: Full-time
- Salary: High-paying package based on experience and expertise
This role is among the most premium and high-demand positions in regulatory affairs, offering global exposure, consulting experience, and strong earning potential.
Application Process
Interested candidates can apply through the official Parexel careers portal:
Apply Here: https://jobs.parexel.com/en/job/-/-/877/91080165264
Candidates are advised to apply early due to the competitive nature of senior regulatory consulting roles.
Why This Role Matters in Healthcare
Regulatory Affairs Consultants play a critical role in bringing new drugs and medical devices to market. By developing global regulatory strategies and ensuring compliance, this role directly impacts patient access to innovative and life-saving therapies.
Working in this position allows professionals to influence regulatory pathways across multiple international markets and contribute to global healthcare advancement.
Frequently Asked Questions (FAQs)
1. Is this role suitable for freshers?
No, this is a senior-level role requiring 7–10 years of experience in regulatory affairs.
2. What type of products will I work on?
You will work on biologics, vaccines, and pharmaceutical products across global markets.
3. What submissions are involved in this role?
IND, NDA, BLA, MAA, DMF, IMPD, and lifecycle variations are key submissions handled.
4. Is this a remote job?
Yes, this role is fully remote within India.
Summary
| Category | Details |
|---|---|
| Company | Parexel |
| Vacancies | Regulatory Affairs Consultant |
| Required Education | B.Pharmacy, M.Pharmacy, Pharm.D, MSc, PhD |
| Experience | 7–10 years |
To apply for this job please visit jobs.parexel.com.
