Parexel, a global leader in clinical research and regulatory consulting, is hiring a Regulatory Affairs Consultant (Labelling) for a remote role in India under Job ID R0000032357. As part of Parexel Consulting, you will play a pivotal role in guiding biopharmaceutical and medical device companies through complex regulatory landscapes, ensuring their products reach the market efficiently and remain compliant.
This role offers the flexibility of remote work, collaboration with diverse global clients, and opportunities for continuous learning in a supportive, innovative environment. If you have expertise in safety labelling and regulatory affairs, join Parexel to make a meaningful impact in the pharmaceutical industry.
Job Opening Overview for Regulatory Affairs Consultant (Labelling)
We are seeking a skilled professional for the following position:
- Position: Regulatory Affairs Consultant (Labelling)
- Category: Consulting
- Job ID: R0000032357
- Location: India, Remote
- Department: Regulatory Affairs
- Application Portal: jobs.parexel.com
Job Description for Regulatory Affairs Consultant (Labelling)
Qualifications
- Bachelor’s or advanced degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences (B.Sc/M.Sc), or related fields from a recognized institution.
- Strong academic background in pharmaceutical sciences or regulatory affairs.
Experience
- 8–9 years of experience in Regulatory Affairs within EU, UK, Switzerland (CH), Australia (AU), or New Zealand (NZ) regulatory frameworks.
- Proven expertise in:
- Safety labelling changes impacting Product Information and managing Artwork (AW) updates from a regulatory perspective.
- Company Core Data Sheet (CCDS) creation or updates (prior experience preferred).
- Change control assessments for regulatory projects.
- Experience with Centralized Products (e.g., EMA-regulated) is a plus.
- Proficiency in Veeva RIMS (Regulatory Information Management System) for regulatory data management.
- Knowledge of the TVT Tool (Translation Verification Tool) is an advantage.
Skills
- Deep understanding of global regulatory requirements for medicinal products, particularly in EU/UK/CH/AU/NZ frameworks.
- Expertise in safety labelling changes and their impact on Product Information.
- Strong analytical skills for CCDS creation/updates and change control processes.
- Proficiency in Veeva RIMS for managing regulatory submissions and documentation.
- Familiarity with TVT Tool for translation verification (preferred but not mandatory).
- Excellent written and verbal communication skills for cross-functional collaboration.
- Ability to work independently in a remote environment while maintaining team synergy.
- Strong organizational skills to manage multiple projects and meet deadlines.
Responsibilities
- Develop and implement regulatory strategies for safety labelling changes impacting Product Information.
- Create or update Company Core Data Sheets (CCDS) to ensure compliance with global regulatory standards.
- Conduct change control assessments to support regulatory projects and submissions.
- Manage Artwork (AW) updates from a regulatory affairs perspective, ensuring alignment with labelling requirements.
- Collaborate with cross-functional teams, including Quality Assurance, Medical Writing, and Clinical Operations, to ensure timely and compliant regulatory submissions.
- Utilize Veeva RIMS for efficient management of regulatory data and documentation.
- Apply knowledge of TVT Tool (if applicable) to verify translations for regulatory submissions.
- Maintain up-to-date knowledge of EU, UK, CH, AU, and NZ regulatory frameworks to ensure compliance.
- Support clients in navigating Centralized Product regulations (if applicable) for EMA submissions.
- Deliver high-quality, on-time regulatory projects, inspired by Parexel’s patient-centric “We Care” philosophy.
Benefits of Joining Parexel
- Flexible Remote Work: Enjoy the freedom to work from anywhere in India while being part of a global team.
- Career Development: Access mentorship from experienced regulatory professionals and challenging assignments across diverse therapeutic areas.
- Innovative Culture: Thrive in a collaborative, inclusive environment rated 3.9/5 for culture and 4.0/5 for career growth (based on employee reviews).
- Global Exposure: Work with leading biopharmaceutical and medical device companies, supporting products in EU, UK, CH, AU, and NZ markets.
- Wellness and Recognition: Benefit from Parexel’s Flexible Work Program and Recognition Program, fostering work-life balance and team appreciation.
- Patient-Centric Mission: Contribute to innovative clinical research that improves patient lives worldwide.
How to Apply for Regulatory Affairs Consultant (Labelling) Role
Interested candidates can apply directly through Parexel’s career portal:
- Application Link: jobs.parexel.com (Job ID: R0000032357)
- Email for Queries: Contact Jobs@Parexel.com for recruitment-related concerns or to report suspicious activity.
Documents to Submit:
- Updated resume highlighting 8–9 years of Regulatory Affairs experience.
- Cover letter detailing expertise in safety labelling, CCDS, and Veeva RIMS.
- Copies of educational certificates (B.Pharm, B.Sc, M.Pharm, M.Sc).
- Experience certificates or references (if applicable).
- Note: Parexel does not charge any fees for recruitment and warns against fraudulent activities by scammers posing as recruiters. If you suspect unauthorized contact, notify Jobs@Parexel.com or report to local law enforcement.
Disclaimer: Always verify job postings through official channels like jobs.parexel.com. Parexel is not responsible for fraudulent offers misrepresenting the company.
Why Join Parexel for Your Regulatory Affairs Career
Parexel, with over 21,000 employees globally, is a trusted Clinical Research Organization (CRO) specializing in regulatory affairs, clinical trials, and pharmaceutical consulting. Our India operations, including hubs in Hyderabad and Bengaluru, are shaping the future of clinical research through innovation and inclusion. By joining our Regulatory Affairs team, you will:
- Work on cutting-edge labelling projects for global markets, ensuring patient safety and regulatory compliance.
- Leverage tools like Veeva RIMS and TVT Tool to streamline regulatory processes.
- Benefit from a remote work model, enabling flexibility while collaborating with a diverse, global team.
- Join a company with a 40-year legacy, recognized for its patient-centric approach and commitment to “With Heart™” values.
- Access opportunities to work on Centralized Products and gain expertise in EU/UK/CH/AU/NZ regulations.
Don’t miss this opportunity to advance your career in regulatory affairs jobs as a Regulatory Affairs Consultant (Labelling) with Parexel. Apply by visiting jobs.parexel.com and join our remote India team to shape the future of pharmaceutical innovation!
