Aquatic Resources Regulatory Specialist conducting aquatic resource delineations and assisting with permit applications for ICF. Collaborating with teams to support environmental compliance and restoration efforts.
About the role
- Director Regulatory Affairs overseeing global regulatory activities and clinical submissions for Oncology products. Requires extensive experience in pharmaceutical regulations and leadership in project teams.
Responsibilities
- provide leadership on global regulatory activities for assigned products
- focus on clinical regulatory filings
- provide regulatory leadership on project teams
- supply, lead and/or supervise IND/CTA and BLA submissions
- interpret regulatory authorities’ feedback, policies, and guidelines
- develop regulatory strategic plans with project teams
- own preparation of major clinical submissions for regulatory approval
- resolve complex project issues
- ensure quality and timeliness of IND/CTA and BLA submissions
- interact with functions and partners in preparation, review, and completion of documents
- assure compliance with regulations and project team timelines
- provide interpersonal support and lead personnel
- critical thinking, strong negotiation and project management skills
Requirements
- 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
- ability to coordinate and prioritize assigned projects according to company goals
- interacting with CROs in managing ex-US/ex-EU CTAs towards clinical trial activations preferred
- strong interpersonal skills both written and verbally
Benefits
- 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)
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