Senior Regulatory Affairs Consultant / Regulatory Project Lead

Parexel International Corporation
United States, Massachusetts, Billerica
8 Federal Street (Show on map)
Jan 12, 2025
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: The ability to build and sustain relationships Critical thinking and problem solving The ability to influence and lead teams Financial management skills Strategic thinking skills Attention to detail and commitment to quality Conflict management skills Consulting skills Contingency planning and risk management skills People management skills Excellent interpersonal, verbal and written communication skills Client focused approach to work A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Bilingual candidates who are fluent in oral and written English and Korean are highly preferred Proficient in Microsoft Excel, Power Point, MS Project and Word. Experience with Parexel systems is a plus Willingness to work in a matrix environment and to value the importance of teamwork. *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. #LI-REMOTE