Strategist, GRA CMC
On-site · Blue Bell, Pennsylvania, United States
Blue Bell, Pennsylvania, United StatesOn-siteFull TimeSenior LevelBachelors DegreeEnterprise
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise
Job Summary
Oversee regulatory affairs operations and design regulatory strategies for global clinical trials. Provide guidance on regulatory requirements, lead interactions with regulatory agencies, manage submissions, and collaborate cross-functionally to meet regulatory objectives. Stay current with regulatory updates and industry trends to inform strategy. This role requires a strong background in regulatory affairs, demonstrated management experience, and a commitment to quality delivery.
Required Qualifications
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry
- Strong knowledge of global regulatory requirements and guidelines
- Proven track record of successful regulatory submissions and interactions
- Excellent communication, leadership, and problem-solving skills
Desired Qualifications
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry
- Proven track record of successful regulatory submissions and interactions
- Strong knowledge of global regulatory requirements and guidelines
- Excellent communication, leadership, and problem-solving skills
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