Regulatory Affairs Specialist Project Lead - Washington, United States - Cynet Systems

Description

• Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory strategy or product portfolio.
• Provide relevant ad hoc regulatory intelligence to internal stakeholders.
• Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on products and goals.
• Coordinate and lead internal teams to develop responses and comments on draft legislation, regulations, guidelines and regulatory policies issues.
• Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on position.
• Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
• Lead proactive advocacy efforts for priority regulatory policy areas.
• Consult with internal experts and leadership to identify priority issues.
• In collaboration with internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies.

• Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
• Minimum 3 years in Regulatory Affairs.
• Established regulatory experience.
• Effective collaboration.
• Familiarity and understanding of the drug/biologic development and commercialization process.
• Excellent written, oral, and presentation communication skills Excellent command of English (written and spoken).
• Superior time management and organizational skills.
• bility to lead multiple complex initiatives (short, mid and long-term).
• Self-motivated, prone to action and results oriented.
• Provides an engaging and motivating work environment.