Senior Regulatory Operations Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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📋 Description

• 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

• 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

• 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

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