Associate Director, Regulatory Operations

Responsibilities:
- Develop and maintain integrated regulatory plans aligned with global development strategies; report submission progress and risks.
- Ensure compliance with global regulatory requirements and timelines.
- Partner with Regulatory Affairs to translate regulatory strategies into actionable operational plans in Veeva.
- Support health authority interaction tracking, commitments, and follow-up.
- Enable structured tracking of regulatory objectives, submissions, and approvals across regions.
- Serve as SME for Veeva RIM (Registrations, Submissions, Submission Content Planning, Regulatory Objectives & Commitment Tracking).
- Optimize workflows, data governance, and lifecycle management within Veeva RIM.
- Develop training materials to ensure adoption and consistent use of RIM processes.
- Lead continuous improvement to enhance system functionality, reporting, and user experience.
- Create/manage Regulatory Operations project plans; support upgrades, enhancements, validation, and issue resolution.
- Establish data standards, naming conventions, and controlled vocabularies.
- Oversee end-to-end submission planning and tracking within Veeva RIM.
- Design/maintain SOPs and work instructions; lead process harmonization and standardization.
- Monitor KPIs/metrics (submission performance, cycle times, system utilization).
- Support governance forums, business transformation, change management (training/communications/adoption).
- Travel ~10%.

Qualifications:
- Bachelor’s degree in life sciences or related field.
- 8+ years in Regulatory Operations (pharma/biotech).
- Global regulatory submission planning, tracking, and lifecycle management experience.
- Deep hands-on Veeva RIM expertise.
- Knowledge of clinical development/regulatory pathways (IND, NDA, BLA, MAA).
- Proficient in Microsoft Word/Excel/PowerPoint; strong English communication.
- Familiar with project management tools (e.g., Microsoft Project, Smartsheet); cross-functional project experience.
- Ability to develop/deliver training; process improvement exposure (Lean/Six Sigma) advantageous.

Skills (preferred/required):
- Analytical use of RIM data; strategic + operational execution; continuous improvement mindset; training/adoption capability.

Benefits:
- Medical, prescription, dental, vision; FSA & HSA with company match; employee assistance; mental health resources; disability coverage; life insurance; critical illness/accident insurance; legal/identity theft protection; pet insurance; fertility/maternity assistance; 401(k) match; flexible time off & 11 paid holidays; paid parental leave.