Senior/ Regulatory Affairs Associate

Qualification

• Knowledge and Experience:
  • A Senior Associate must have an understanding and experience of consulting models and methodologies
  • A Senior Associate must have good knowledge of regulatory requirements of IND/CTA/NDA and have experience of filing clinical trial application or import license application successfully to health authorities.
  • A Senior Associate shall have experience of taking a Technical SME for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the client.
  • A Senior Associate may act in a client facing role. When serving as a Project Lead or Work Stream Lead, a Senior Associate assures the work of the entire team or work stream is delivered on time and that it meets client’s and Parexel's quality expectations.
  • More than 3 years of experience in regulatory affairs or SSU for clinical trials
• Education:
  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline. BPharm degree is a plus.

Key Accountabilities:

Project Execution-

• Works effectively within a team environment but may work independently delivering services within their area of competence
• Works within broad project guidelines as directed by the project lead and/or technical SMEs
• Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager
• May serve as a Project Lead or a Work Stream Lead.  PL shall be responsible for project planning and set-up, till all project close-out activities are completed, which could include project delivery of scoped work, project financials, forecasts, training compliance, risk identification/issue escalation with solutions, etc.

Consulting Activities and Relationship Management

• Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
• Delivers consulting services within personal area of expertise under the guidance of the project lead and/or Technical SME
• Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the Project Lead and/or Technical SME
• Identifies project and internal issues to senior colleagues and Project Lead and/or technical SME and provides proposed solutions

Business Development

• Communicates potential new business leads to consulting management and account managers
• May participate in project scoping calls and/or proposal preparation with the support of senior colleagues