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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions, particularly with U.S. FDA electronic submissions and eCTD formats, while ensuring compliance with ICH and FDA standards. Strong organizational and communication skills facilitate effective collaboration with cross-functional teams and regulatory partners.
Highest-signal resume keywords
Regulatory Operations ExperienceECTD Submission PreparationVeeva Vault RIM ProficiencyUnderstanding of ICH and FDA StandardsDetail-Oriented Organizational Skills
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 SubmissionsECTD SpecificationsIND SubmissionNDA SubmissionBLA SubmissionSafety Reports ManagementDocument ControlQuality Control ChecksMetadata TaggingSubmission Workflow Management
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationDetail-OrientedOrganizational SkillsIndependent Work Ability
Tools & Technologies
Veeva Vault RIMMicrosoft WordAdobeMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
Pharmaceutical IndustryRegulatory ComplianceHealth Authority RegulationsSubmission GuidelinesLifecycle Management
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Plan, prepare, publish, and manage regulatory submissions to global health authorities, focusing on U.S. FDA electronic submissions.
- Review data and reports for scientific accuracy and clarity before incorporation into regulatory submissions.
- Prepare, compile, and review submissions for compliance with health authority regulations, guidelines, and company policies/procedures.
- Manage routine submissions such as safety reports, investigator updates, and IND Annual Reports.
- Maintain and oversee submission workflows within Veeva Vault RIM or equivalent RIMS.
- Create timelines and submission plans, and track deliverables to ensure on-time submissions and approvals.
- Ensure submissions meet regulatory, technical, and formatting requirements, including FDA eCTD specifications and ICH M4.
- Ensure document control, metadata tagging, and archival of submission components.
- Conduct quality control checks for accuracy, technical compliance, and completeness before submission.
- Interface with Regulatory partners and internal cross-functional teams.
Requirements
What you’ll need- Bachelor’s degree and 2-3 years’ directly related experience.
- 2-3 years’ experience in Regulatory Operations within the pharmaceutical industry.
- Experience with Veeva Vault RIM.
- Proven experience preparing and submitting eCTD submissions (INDs, NDAs, BLAs, amendments, supplements, and annual reports) to FDA and/or global agencies.
- Strong understanding of ICH, FDA, and regional electronic submission standards and lifecycle management.
- Proficient in Microsoft Word, Adobe, Excel, and PowerPoint.
- Excellent written and verbal communication skills.
- Detail-oriented with well-developed organizational skills.
- Able to work efficiently and independently.
Benefits
Comp & perks- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits
- HSA match
- 401k match
- Employer paid life and disability insurance
- Pet insurance
- Wellness discounts