Senior Regulatory Affairs Operations Specialist
Bausch Health Companies Inc.
2 hours ago
Remote friendly (Bridgewater, NJ)
United States
Operations
Senior Specialist – Regulatory Operations
Key Responsibilities:
- Publish regulatory submissions in various formats including eCTD/NeeS; perform quality control reviews of publishing outputs; dispatch submissions to Health Authorities (US FDA, Health Canada).
- Prepare, dispatch, and archive OPDP 2253 submissions.
- Coordinate with RA Strategy and/or CMC Leads to ensure content accuracy and identify issues impacting compliance or timelines.
- Ensure final documents are submission-ready and compliant with applicable Health Authority requirements; address advanced document/technical issues as needed.
- Archive regulatory submissions and related correspondence per established retention strategies; maintain accurate records in RIM systems.
- Assist in development and maintenance of Regulatory Operations best practices; contribute to process improvements to enhance efficiency and quality.
- Perform other responsibilities as assigned.
Qualifications & Preferred Requirements:
- Bachelor’s degree (preferred).
- Experience with preparation, publishing, and archiving of regulatory documents; tracking status in RIM systems (e.g., Veeva RIM).
- Knowledge of FDA and Health Canada eCTD submission lifecycle management, guidance, specifications, and regulations.
- Proficiency in eCTD format and regulatory submission requirements.
- Working knowledge of document management systems and regulatory publishing tools (preferably Veeva RIM and docuBridge).
- Ability to balance multiple tasks and meet priorities/timelines.
- Experience managing submissions/timelines and collaborating with team members.
- Strong communication skills and ability to work effectively in a team.
- Minimum 3 years of combined pharmaceutical and regulatory experience (preferred).
Benefits:
- Medical (includes Prescription Drug), dental, vision, Flexible Spending Accounts, 401(k) with matching, 3 weeks paid time off plus paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses, employee discounts.
Work Model:
- Hybrid (Bridgewater, NJ; Tuesday, Wednesday, Thursday in office).
Key Responsibilities:
- Publish regulatory submissions in various formats including eCTD/NeeS; perform quality control reviews of publishing outputs; dispatch submissions to Health Authorities (US FDA, Health Canada).
- Prepare, dispatch, and archive OPDP 2253 submissions.
- Coordinate with RA Strategy and/or CMC Leads to ensure content accuracy and identify issues impacting compliance or timelines.
- Ensure final documents are submission-ready and compliant with applicable Health Authority requirements; address advanced document/technical issues as needed.
- Archive regulatory submissions and related correspondence per established retention strategies; maintain accurate records in RIM systems.
- Assist in development and maintenance of Regulatory Operations best practices; contribute to process improvements to enhance efficiency and quality.
- Perform other responsibilities as assigned.
Qualifications & Preferred Requirements:
- Bachelor’s degree (preferred).
- Experience with preparation, publishing, and archiving of regulatory documents; tracking status in RIM systems (e.g., Veeva RIM).
- Knowledge of FDA and Health Canada eCTD submission lifecycle management, guidance, specifications, and regulations.
- Proficiency in eCTD format and regulatory submission requirements.
- Working knowledge of document management systems and regulatory publishing tools (preferably Veeva RIM and docuBridge).
- Ability to balance multiple tasks and meet priorities/timelines.
- Experience managing submissions/timelines and collaborating with team members.
- Strong communication skills and ability to work effectively in a team.
- Minimum 3 years of combined pharmaceutical and regulatory experience (preferred).
Benefits:
- Medical (includes Prescription Drug), dental, vision, Flexible Spending Accounts, 401(k) with matching, 3 weeks paid time off plus paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses, employee discounts.
Work Model:
- Hybrid (Bridgewater, NJ; Tuesday, Wednesday, Thursday in office).