Senior Regulatory Affairs Specialist
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Remote • Texas • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Assembly
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsdrug listing submissionsdocument managementregulatory strategyregulatory fee paymentsproject management
Soft skills
communication skillsorganization skillsanalytical skillsproblem-solving skillsability to trainability to prioritize
Certifications
Bachelor’s Degree