Great opportunity to work as Senior Regulatory Affairs Associate at PAREXEL-Apply before 20th March 2024




PAREXEL is a prominent global biopharmaceutical service provider that plays a crucial role in supporting the Bio-Tech and Pharmaceutical industries. They contribute to the development of new drugs and treatments on a global scale. PAREXEL offers knowledge-based services, including contract research, medical communications, and consulting across various therapeutic areas. Their clients span the worldwide pharmaceutical, biotechnology, and medical device industries.

Post: Senior Regulatory Affairs Associate (Labeling)

Job Description:

We are seeking a highly skilled and experienced Senior Regulatory Affairs Associate specializing in labeling for our dynamic team. The ideal candidate will have a significant background in drug development, with a focus on labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Key responsibilities include:

  • Labeling Regulations Expertise: Demonstrate a strong working knowledge of key labeling regulations/guidance, with a proven track record in label development, including CCDS, USPI, and packaging.
  • Comparator Labeling: Research and create comparator labeling documents to ensure compliance and accuracy.
  • Annual Reports: Possess a robust understanding and past experience in creating annual reports, contributing to regulatory compliance and reporting.
  • Collaboration with Tech Ops: Ability to collaborate effectively with Technical Operations for seamless artwork implementation.
  • SPL Proficiency: Showcase proficiency in Structured Product Labeling (SPL), covering all aspects, types, and troubleshooting. Manage the review and approval of labeling in a document management system.
  • Electronic Document Management: Experience in using electronic document management systems and/or electronic submission, ensuring efficient regulatory processes.
  • Life Cycle Management: Contribute to Life Cycle Management activities, particularly Post Approval Labeling submissions, including PSUR submissions.

Additional Information:

  • Location: Hyderabad, Telangana, India
  • Industry Type: Pharma / Healthcare / Clinical Research
  • Functional Area: Regulatory / Consulting
  • End Date: 20th March 2024

If you are a dedicated regulatory affairs professional with a strong background in labeling and a passion for contributing to the development of new drugs, we invite you to apply. Join our team and play a pivotal role in shaping the regulatory landscape in the pharmaceutical industry.

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