Job

Seeking a regulatory professional who will be responsible for leading the global regulatory strategy for expansion of our development product(s) into international markets.

Responsibilities

• Develop global regulatory strategy (including clinical/nonclinical, CMC and global labeling) for product(s)that are in alignment with overall global product strategy, market timing plans and corporate goals
• Participate/lead regional health authority meetings
• Lead preparation of regulatory documentation especially clinical/nonclinical content for global markets in partnership with Regulatory regional leads and GRL
• Lead the development of global dossier strategy to support international marketing applications for assigned product
• Participate/lead relevant functional area and project team meetings

Experience/Skills

• 10-15years of industry experience in Regulatory Affairs or a related discipline
• Prior experience as a Global Regulatory Lead
• Ability to develop and maintaining strong connections with regional and country leads
• Regulatory information expert with prior experience developing product approval strategies
• Proven track record of managing critical projects as a part of an interdisciplinary team
• Prior experience managing regulatory submissions to deadlines
• Experience managing a small team or at a minimum management in a matrix setting

Education

• BA/BS degree in life sciences
• Advanced degree a plus