Senior Regulatory Professional managing regulatory submissions for Obesity & Cardiometabolic Health therapies. Driving strategies that impact patients' access to treatment across global markets.
Responsibilities
Shape regulatory strategies for Obesity & Cardiometabolic Health therapies
Lead end-to-end regulatory submissions to health authorities worldwide
Plan and conduct regulatory interactions with health authorities
Develop and maintain core labelling
Serve as a Regulatory Affairs process expert
Mentor junior colleagues and contribute to team development
Requirements
PhD, Master's or Bachelor's degree in life sciences
9+ years of relevant regulatory affairs experience
7-9 years of work experience demonstrating solid regulatory affairs qualifiers
Proven track record with China, Japan, US and EU submission experience
Strong knowledge of regulatory therapeutic areas
Demonstrated ability to work independently with high initiative
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