Provide leadership on global regulatory activities for the assigned products.
Focus on Clinical Regulatory filings and provide regulatory leadership on project teams.
Supply, lead and/or supervise IND/CTA and BLA submissions activities.
Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
Lead the development of regulatory strategic plans in conjunction with project teams or through your reports.
Own the preparation of major clinical submissions required for regulatory approval.
Work with project teams to resolve complex project issues.
Utilize regulatory expertise and knowledge of regulatory requirements and regulations to interpret, plan, and communicate requirements.
Assure compliance with regulations and project team timelines.
Provide interpersonal support and lead personnel.

MD, Ph.D. or Pharm D. degree
minimum of 10 years of pharmaceutical industry experience
at least 7 years of regulatory experience
strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
strong interpersonal skills both written and verbally
high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees at all levels!

Director, Regulatory Affairs Strategy – Oncology

Key skills