Senior Regulatory Affairs Associate

1 month ago


India Parexel Full time

Key Accountabilities:

Project Execution:


Regulatory Affairs Labeling

  • Must have 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
  • Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
  • The ability to research and create comparator labeling documents.
  • Strong understanding and experience creating annual reports.
  • The ability to collaborate with Tech Ops for artwork implementation.
  • Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
  • Electronic document management systems use and / or electronic submission experience.
  • Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.



PAREXEL-related Activities:

  • Meets established metrics as specified in scorecard on an annual basis
  • Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management
  • Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)


Skills:

  • 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
  • Proficiency in local language and extensive working knowledge of the English language


Business Development:

  • Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
  • Communicates potential new business leads to PC management and account managers
  • May participate in project scoping calls and/or proposal preparation with the support of senior colleagues


Knowledge and Experience:

  • 4+ years of experience in an industry-related environment


Education:

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline



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