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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in US regulatory activities for pharmaceutical and biologic products, including regulatory submissions, labeling development, and lifecycle management. Strong organizational and communication skills are essential for managing multiple projects and collaborating with cross-functional teams.
Highest-signal resume keywords
US Regulatory ActivitiesRegulatory SubmissionsLabeling DevelopmentLifecycle ManagementStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory DocumentationSubmission TrackingProduct StewardshipQuality Change EvaluationRegulatory Operations
Soft Skills
Organizational SkillsEffective CommunicationProject Management
Tools & Technologies
Regulatory SystemsDocument Workflows
Industry Keywords
Pharmaceutical ProductsBiologic ProductsAnimal Health Regulatory Experience
About the role
Key responsibilities & impact- Support US regulatory activities for pharmaceutical and biologic products across multiple programs and clients
- Prepare, coordinate, and support regulatory submissions, registrations, annual reports, and post-approval changes
- Support labeling development, review, approval, implementation, and maintenance activities
- Maintain regulatory documentation, correspondence, submission trackers, and product information
- Support regulatory operations, document workflows, submission tracking, and records management
- Contribute to lifecycle management and product stewardship activities across the product lifecycle
- Evaluate product, labeling, manufacturing, and quality changes for potential regulatory impact
- Collaborate with Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, Commercial, and other stakeholders
- Support onboarding, training, knowledge transfer, and regulatory systems activities
- Ensure deliverables comply with procedures, client expectations, and US regulatory requirements
- Manage multiple priorities and communicate risks, issues, or delays in a timely manner
- Support broader US regulatory consulting activities as business and client needs evolve
Requirements
What you’ll need- Experience supporting US regulatory activities for pharmaceutical and/or biologic products
- Familiarity with regulatory submissions, labeling, lifecycle management, and regulatory operations
- Strong organizational skills with the ability to manage multiple projects and deadlines
- Effective communication and stakeholder management skills
- Experience working in a consulting, client-facing, or cross-functional environment is a plus
- Animal Health regulatory experience is desirable, but not required
Benefits
Comp & perks- Medical, dental, and vision care
- Backup dependent care
- Adoption assistance
- Infertility coverage
- Family building support
- Behavioral health solutions
- Paid parental leave
- Paid caregiver leave
- Training programs
- Professional development resources
- Mentorship programs
- Employee resource groups
- Volunteer activities
- Reasonable accommodations during the employment process