Director, Regulatory Affairs, Ex-US
$120,000–$150,000 year
On-site · Philadelphia, Pennsylvania, United States
Job Summary
The Director of Regulatory Affairs ex-US will drive global regulatory activities for products in development, focusing on European and other global regions. Responsibilities include leading regulatory submissions to health authorities, providing tactical advice to project teams for program development and approval, preparing assessments of global regulatory intelligence, and collaborating with various departments to create promotional materials. Candidates should have a Bachelor's degree in a relevant field, experience in regulatory submissions, and a deep understanding of regulatory environments.
Required Qualifications
- Bachelor's degree in a relevant scientific discipline
- Experience in regulatory affairs within the biotechnology or pharmaceutical industry
- Strong understanding of global regulatory environments and ICH guidelines
- Proven track record of leading successful regulatory submissions
Desired Qualifications
- Experience in regulatory submissions for biotechnology products
- Expertise in European regulatory processes
- Strong leadership and collaboration skills
- Ability to develop and implement regulatory strategies
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