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Parexel

Regulatory Affairs Consultant

Parexel

Posted

3 weeks ago

Serilingampalli, Telangana

Remote

INR 60K

Mid Level

Full Time

Match

Skills

Experience

Industry

Sema

Sema Summary

As a Regulatory Affairs Consultant specializing in Biologics, you will be responsible for ensuring compliance with regulations and standards in the healthcare sector. This position requires a deep understanding of regulatory processes and the ability to manage documentation. You will work closely with cross-functional teams to facilitate the approval of biologic products. The role is suitable for mid-level professionals with prior experience in regulatory affairs, ensuring that candidates possess relevant skills and experience. This is a full-time remote position based in India, offering a competitive salary and potential opportunities for career growth.

About Company

Parexel is a leading global biopharmaceutical services company that helps clients accelerate the development of innovative new drugs. With a commitment to providing quality regulatory affairs services, Parexel supports companies in navigating complex healthcare regulations.

Core Requirements

  • Bachelor's degree in a related field
  • Experience in regulatory affairs
  • Knowledge of biologics regulations
  • Strong communication skills
  • Attention to detail

Responsibilities

  • Manage regulatory submissions for biologics
  • Ensure compliance with local regulations
  • Collaborate with internal teams on product development
  • Prepare documentation for regulatory reviews
  • Monitor changes in regulatory guidelines
  • Advise clients on regulatory strategy
  • Conduct risk assessments related to regulations

Must Have skills

Regulatory knowledgeProject managementAnalytical skillsDocumentation skillsProblem-solving

Nice To Have Skills

Clinical research experienceTeam collaborationPresentation skillsTime managementBiologics expertise

Tools Knowledge Requried

Regulatory SoftwareMS OfficeProject Management Tools

Job Keywords

Regulatory AffairsBiologicsHealthcare ComplianceConsultingDocumentation

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