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Opportunity to Join PAREXEL as Regulatory Affairs Associate- Appluy before 20th May 2024

Parexel
Pharmacareer

Website PAREXEL

About PAREXEL

PAREXEL is a global clinical research organization that provides a range of services to the biopharmaceutical industry. They offer expertise in areas such as clinical trials, regulatory affairs, market access, and pharmacovigilance. PAREXEL helps pharmaceutical companies navigate the complex process of bringing new drugs to market by providing support at every stage of drug development, from initial clinical trials to regulatory approval and post-market surveillance. Their services aim to streamline the drug development process, accelerate timelines, and ensure compliance with regulatory requirements.

Regulatory Affairs Associate

Job Description:

  • Understanding Regulatory Framework: Familiarize with regulatory frameworks and regional trends for various application types and procedures for both small and large molecules across global regions.
  • Providing Regulatory Input: Offer regulatory insights on procedural and CMC (Chemistry, Manufacturing, and Controls) documentation requirements as per Health Authorities’ guidelines for assigned deliverables. This includes strategizing submission delivery, document review, and analysis of regulatory procedures throughout product development.
  • Cross-functional Collaboration: Collaborate closely with cross-functional team members with aligned product responsibilities to ensure regulatory compliance and alignment.
  • Submission Management: Develop, execute, and maintain submission delivery plans and content plans. Provide proactive status updates to designated stakeholders throughout the submission process.
  • Dossier Authoring: Author dossier sections based on changes to approved Marketing Authorization Applications (MAA) and ensure compliance with regulatory guidelines.
  • Change Management: Possess knowledge of change evaluation procedures according to country-specific guidelines.
  • EU Market Lifecycle Management: Experience in managing lifecycle activities within the EU markets is preferred.
  • CTD Guidelines: Familiarity with Common Technical Document (CTD) guidelines for regulatory submissions.

Candidate Profile:

  • Experience: 2 to 5 years of experience in Regulatory Affairs-CMC, with a willingness to work in EU shifts.

Additional Information:

  • Experience: 2 to 5 years
  • Location: Hyderabad, India
  • Industry Type: Pharma/ Healthcare/ Clinical Research
  • Functional Area: Regulatory Affairs
  • End Date: 20th May 2024
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To apply for this job please visit jobs.parexel.com.