Senior Regulatory Operations Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Strategize, prepare, publish, and oversee regulatory submissions to global health authorities, with a focus on electronic submissions to the U.S. FDA.

• Assess data and reports for scientific precision and clarity prior to their inclusion in regulatory submissions.

• Assemble, compile, and evaluate submissions for adherence to health authority regulations, guidelines, and internal company policies/procedures.

• Handle routine submissions including safety reports, investigator updates, and IND Annual Reports.

• Maintain and manage submission workflows within Veeva Vault RIM or a comparable RIMS.

• Develop timelines and submission strategies, and monitor deliverables to ensure timely submissions and approvals.

• Confirm that submissions comply with regulatory, technical, and formatting standards, including FDA eCTD specifications and ICH M4.

• Ensure proper document control, metadata tagging, and archival of submission components.

• Perform quality control checks for accuracy, technical compliance, and completeness ahead of submission.

• Collaborate with Regulatory partners and internal cross-functional teams.

⛳️ Requirements

• Bachelor’s degree alongside 2-3 years of directly related experience.

• 2-3 years of experience in Regulatory Operations within the pharmaceutical sector.

• Familiarity with Veeva Vault RIM.

• Demonstrated experience in preparing and submitting eCTD submissions (INDs, NDAs, BLAs, amendments, supplements, and annual reports) to the FDA and/or global agencies.

• Strong grasp of ICH, FDA, and regional electronic submission standards and lifecycle management.

• Proficient in Microsoft Word, Adobe, Excel, and PowerPoint.

• Exceptional written and verbal communication abilities.

• Detail-oriented with strong organizational competencies.

• Capable of working efficiently and independently.

🏝️ Benefits

• Competitive compensation package, including base salary and annual performance bonus.

• Flexible paid time off (PTO), holidays, and parental leave.

• Comprehensive healthcare benefits.

• Health Savings Account (HSA) match.

• 401k match.

• Employer-funded life and disability insurance.

• Pet insurance.

• Discounts on wellness programs.