Principal Regulatory Strategist (CRO/Pharma Industry) - Remote
- Seattle, WA
- Permanent
- Full-time
- Provide consulting and advisory services for complex regulatory issues or projects.
- Author and maintain documentation as required to sustain regulatory compliance.
- Provide senior technical review for complex regulatory projects.
- Provide cross-functional team leadership and management of multiple stakeholders across diverse projects
- Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
- Participate in project teams and provide expertise on related regulatory matters.
- Clearly and accurately conveys information to peers, supervisors, and other stakeholders.
- Participates in in implementation of new/updated operational strategies to comply with new/updated policies and recommendations.
- Identifies new/updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc.).
- College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
- Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA).
- Expert knowledge of regulatory principles and concepts.
- Reputation as experienced leader with evidence of sustained performance and accomplishments.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.