Senior Regulatory Affairs Specialist
Location
Texas
Posted
88 days ago
Salary
Not specified
Bachelor Degree3 yrs expEnglishAssembly
Job Description
• Manage preparation, assembly, publishing, and submissions of US and Canadian regulatory applications
• Support key regulatory affairs consultants with expertise in regulatory strategy and processes
• Draft and manage regulatory submissions and drug listing submissions
• Coordinate regulatory fee payments on behalf of clients
• Maintain knowledge of changing regulatory requirements
• Liaise with regulatory authorities on behalf of clients
• Build and maintain working relationships with clients
• Conduct issue resolution and communicate with clients
• Perform document management tasks
• Maintain familiarity with global regulatory submission standards
Job Requirements
- Bachelor’s Degree
- 3-5 years’ experience in Regulatory Affairs or equivalent
- Experience working in the pharmaceutical industry
- Understanding of FDA and Canadian Regulatory Affairs procedures
- Ability to prioritize and drive multiple projects
- Ability to train and support junior/new colleagues
- Previous hands-on experience with regulatory submissions
- Ability to maintain confidentiality and respond to client needs
- Outstanding organization, analytical, and problem-solving skills
- Excellent written, verbal and presentation communication skills
Benefits
- Health insurance
- 401(k) matching
- Paid parental leave
- Adoption assistance
- Infertility coverage
- Family building support
- Backup dependent care
- Paid caregiver leave
- Behavioral health solutions
- Professional development resources
- Mentorship programs
- Volunteer activities
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