Parexel Hiring Pharma Graduates for Regulatory Affairs Role – Apply Now
Looking for a Regulatory Affairs Job with remote work flexibility? Parexel Careers is hiring a Regulatory Affairs Associate in India, with Bengaluru listed as an additional location. The role is focused on European post-approval regulatory activities, CMC documentation, lifecycle management, regulatory submissions, and maintenance of marketing authorizations.
- Position: Regulatory Affairs Associate
- Location: India, Remote
About The Company
Parexel is a global biopharmaceutical services organization that provides a wide range of solutions to help clients navigate the complex regulatory landscape. With a focus on innovation and client success, Parexel operates in various therapeutic areas, ensuring that products reach the market efficiently while adhering to regulatory standards. The company is committed to fostering a collaborative environment that promotes continuous learning and professional development, making it an ideal workplace for those interested in Parexel careers.
Job Description
The Regulatory Affairs Associate at Parexel will play a critical role in supporting lifecycle management activities and regulatory submissions for medicinal products. This position requires expertise in regulatory affairs, particularly in post-approval processes. The successful candidate will collaborate with clients to develop regulatory strategies that facilitate faster market access while ensuring compliance with applicable regulations. This role offers the opportunity to work with various product types and therapeutic areas, enhancing professional growth within the regulatory affairs field.
Key Responsibilities
- Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.
- Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
- Manage and maintain regulatory change records within Veeva RIMS.
- Support implementation of regulatory strategies for post-approval changes.
- Review, update, and author
- Module 3 sections of CTD dossiers for medicinal products.
- Ensure CMC documentation remains current and compliant with regulatory expectations.
- Support dossier lifecycle maintenance activities across multiple markets.
- Conduct comprehensive
- Gap Analysis of Module 3 documentation.
- Identify compliance risks, data gaps, and documentation deficiencies.
- Develop and recommend remediation plans and regulatory strategies to address identified gaps.
- Manage post-approval regulatory activities throughout the product lifecycle.
- Support maintenance of marketing authorizations across EU markets.
- Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.
Eligibility Criteria
- Minimum 3+ years of experience in post-approval regulatory activities for medicinal products registered through European procedures, including CP, MRP, DCP, and National Procedures.
Required Skills
- EU Regulatory Affairs
- Post-Approval Activities
- CTD Module 3
- CMC Documentation
- Regulatory Impact Assessment
- Veeva RIMS
- TrackWise
- Gap Analysis
- Lifecycle Management
- Regulatory Compliance
Why Join Parexel?
By joining Parexel, candidates will become part of a dynamic team that values collaboration and innovation. The organization emphasizes continuous learning and provides opportunities for mentorship from experienced regulatory professionals. Working remotely allows employees to maintain a healthy work-life balance while contributing to impactful projects in the biopharmaceutical industry. Parexel careers offer a unique chance to grow professionally while making a difference in the regulatory affairs landscape.
This Regulatory Affairs Job provides an opportunity to develop expertise in European regulatory procedures, post-approval changes, CMC documentation, and product lifecycle management. Parexel Careers also offers exposure to diverse clients and therapeutic areas while providing the flexibility of remote work.
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