Senior Regulatory Affairs Consultant

2 days ago


Billerica MA United States Parexel International Corporation Full time

If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E-X-P-A-N-D-I-N-G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight-knit team of amazingly nice and extremely experienced colleagues

As a Senior Regulatory Affairs Consultant / Regulatory Project Lead, you will provide leadership to highly experienced project teams and manage the day-to-day operations and complexities of preparing and filing NDA and/or BLA applications. You will strive to achieve operational excellence through on-time delivery that is within budget and to the highest quality with the goal to exceed client expectations.

Qualifications:

Successful candidates must at minimum, possess an undergraduate degree in a clinical or health-related field: advanced degree preferred, along with at least 10-15+ years' experience working in a similar capacity leading US FDA filings within a CRO, Biotech, or a Pharmaceutical Company (previous CRO or Consulting firm experience is highly preferred). Past experience overseeing a cross-functional team involved in the creation of US Regulatory Filings to include NDAs and/or BLAs is required. Previous vaccines experience is a plus

This position also requires experience in project scheduling, managing resources and budgets, and coordinating team activities, as well as experience in Regulatory Affairs related activities.

Successful candidates must also possess the following:

  1. The ability to build and sustain relationships
  2. Critical thinking and problem solving
  3. The ability to influence and lead teams
  4. Financial management skills
  5. Strategic thinking skills
  6. Attention to detail and commitment to quality
  7. Conflict management skills
  8. Consulting skills
  9. Contingency planning and risk management skills
  10. People management skills
  11. Excellent interpersonal, verbal and written communication skills
  12. Client focused approach to work
  13. A flexible attitude with respect to work assignments and new learning
  14. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  15. Bilingual candidates who are fluent in oral and written English and Korean are highly preferred
  16. Proficient in Microsoft Excel, Power Point, MS Project and Word
  17. Experience with Parexel systems is a plus
  18. Willingness to work in a matrix environment and to value the importance of teamwork
  19. Experience with financials and managing project budgets

Up to approximately 20% Domestic and/or International Travel may be required in the future.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination. #J-18808-Ljbffr

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