Regulatory Affairs Specialist

1 month ago

Hyderabad, Telangana, India Parexel Full time
Job Description

We are seeking a highly experienced Regulatory Affairs Specialist to join our team at Parexel.

About the Role:

  • Lead and/or contribute to the planning, preparation, authoring, and delivery of regulatory maintenance submissions from a global and/or regional perspective.
  • Manage (authoring and review) biologics/biosimilar/vaccine investigational product submissions such as IND & IMPD for USFDA, EMA, and other global markets.
  • Author, review, and submit BLA/MAA dossiers for US/EU/ROW/India markets, including post-approval submissions for Biosimilars.
  • Evaluate change controls and deviations, defining regulatory strategy and preparing scientific advice, briefing book, Type 2 meeting packages for USFDA and EMA.
  • Develop up-to-date knowledge about regulatory guidelines and apply regulatory requirements and their impact on submissions.

About You:

  • 7-10 years of relevant experience in handling pre- and post-approval life cycle management of drug products.
  • Good understanding of the regulatory framework, including regional trends, for various types of applications and procedures.
  • Strong communication skills and ability to guide and mentor team members.
  • Ability to work independently and manage multiple priorities.

Requirements:

  • Project management knowledge.
  • Client-focused approach to work.
  • Results orientation.
  • Teamwork and collaboration skills.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
  • Critical thinking and problem-solving skills.

Parexel-related Activities:

  • Meet established metrics as specified in scorecard on an annual basis.
  • Complete basic job-related responsibilities, including timesheets, expense reports, CVs, training compliance, project deliverable archiving, and participation in internal initiatives/projects.
  • Define self-development activities to maintain current industry knowledge.

Salary:$140,000 - $160,000 per annum, depending on location and experience.

Benefits:Comprehensive health insurance, retirement plan, paid time off, and professional development opportunities.

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