Sr Manager of Regulatory Affairs
NSP · Lehi, UT · 2 wk ago
On-siteManagementFull-time
About the role
The Sr Manager of Regulatory Affairs is responsible for overseeing regulatory compliance across various departments within the organization. This includes developing and implementing strategies to ensure all products and operations adhere to relevant regulations.
Responsibilities
- Develop and enforce regulatory compliance policies and procedures
- Monitor regulatory changes and their impact on business operations
- Collaborate with cross-functional teams to ensure regulatory requirements are met
- Conduct internal audits to assess compliance with regulatory standards
- Prepare and present regulatory updates to senior management
Requirements
- Bachelor’s degree in a related field (e.g., Pharmacy, Biology, Law)
- Minimum 5 years of experience in regulatory affairs or a similar role
- Proven track record in managing regulatory compliance programs
- Strong understanding of FDA, EU, and other international regulations
- Excellent communication and interpersonal skills
Qualifications
- Knowledge of pharmaceutical, biotech, or medical device industry regulations
- Experience with regulatory submissions and inspections
- Ability to work independently and manage multiple projects simultaneously
- Proficiency in Microsoft Office Suite
Skills
- Strong analytical and problem-solving skills
- Excellent organizational and time management skills
- Ability to prioritize tasks and meet deadlines
- Effective written and verbal communication skills
Benefits
- Competitive salary package
- Flexible working hours
- Professional development opportunities
- Health insurance benefits
- Employee wellness programs
Pay
Commensurate with experience
Schedule
Full-time
Benefits
- Health insurance benefits
- Employee wellness programs
Contact Information
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