global regulatory lead.burlington, massachusettsposted 6 days ago job detailssummary$115 - $135 per hourcontractpostgraduate degreecategorylife, physical, and social science occupations reference 54424 job details job summary: Take the reins on high-stakes oncology programs and steer global regulatory strategy from concept to Health Authority approval. In this remote leadership role, you'll direct cross-functional regulatory sub-teams, lead critical FDA and EMA interactions, and directly shape global submission pathways for cutting-edge therapies.

location:

Telecommute job type: Contract salary: $115 - 135 per hour work hours: 9 to 5 education: Masters responsibilities: Represent Regulatory Affairs in Global Project Team(s) for your assigned project(s).Lead the regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functions.

Drive the regulatory submission process for all types of submissions through to approval. This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality. Partner with Regulatory Project Management and Submission Management.

Ensure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes. This may be done by an experienced Regional Regulatory Lead with strong support from the GRL.Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.

Matrix leadership role of GRST - ensure project resource requirements are suitably managed.

Participate in cross-functional and GRA initiatives qualifications:

Required:

Advanced degree and at least 6 years of relevant experienceA minimum of 3 years of recent oncology experienceExperienced strategist with a record of successful HA interactions with FDA or EMADemonstrated strong matrix leader #LI-KH1 skills: European Medicines Agency (EMA), Food and Drug Administration (FDA),

FDA Submissions Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.