Associate Director - RA Global Reg Strategy, US & Canada

2 days ago

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AbbVie

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Biopharmaceutical • Biotechnology • Innovation • Research and Development • Manufacturing

10,000+

Description

• Responsible for development and implementation of US and Canada regulatory strategies • Manage interface with Health Authority (FDA) for key projects/issues • Coordinate preparation of FDA meeting briefing packages and responses • Advise internal customers on Regulatory/FDA issues • Demonstrates excellent negotiation skills and problem solving skills • Assures complete and timely response to Health Authorities during application review • Present regulatory information to appropriate cross-functional areas • Operates in compliance with regulations, company policies and procedures

Requirements

• Required Education: Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences • Preferred Education: Relevant advanced degree is preferred. Certification a plus. • Required Experience: 8 years Regulatory, R&D or Industry-related experience • Preferred Experience: 5 years in pharmaceutical regulatory affairs • Effective communication skills in written and oral channels both within Regulatory and across the organization • Extensive experience interfacing with government Agencies and Health Authority personnel • Experience working in a complex and matrix environment • Proven skill at implementing successful US and Canada regulatory strategies

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick) • Medical/dental/vision insurance • 401(k) to eligible employees • Short-term incentive programs • Long-term incentive programs