Summary:

The Associate Director, Regulatory Operations is responsible for driving the execution of global regulatory strategy, ensuring alignment with health authority requirements and corporate objectives. This role will lead submission planning, tracking, and cross-functional coordination to enable timely delivery of regulatory milestones. In support of these efforts, they will optimize regulatory processes and leverage Veeva RIM functionality as a subject matter expert (SME), enhancing system effectiveness, operational efficiency, and overall process excellence.

Responsibilities

Essential Duties and Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Develop and maintain integrated regulatory plans aligned with global development strategies; provide portfolio-level visibility and reporting to leadership on submission progress and risks.
• Ensure consistency and compliance with global regulatory requirements and timelines.
• Partner with Regulatory Affairs leads to translate regulatory strategies into actionable operational plans within Veeva.
• Support Health Authority interaction tracking, commitments, and follow-up activities.
• Enable structured tracking of regulatory objectives, submissions, and approvals across regions.
• Serve as the SME for Veeva RIM, with deep expertise across modules (e.g., Registrations, Submissions, Submission Content Planning, Regulatory Objectives and Commitment Tracking).
• Support workflow optimization, data governance, and lifecycle management within Veeva RIM.
• Develop and deliver training programs and materials to ensure effective adoption and consistent use of RIM processes.
• Lead continuous improvement initiatives to enhance system functionality, reporting, and user experience.

• Create and manage Regulatory Operations project plans for assigned projects; collaborate with Regulatory Affairs colleagues, cross-functional team members or other stakeholders to ensure that projects are completed with the deliverables and timelines described in the projects' scope of work.

• Support system upgrades, enhancements, validation support, and issue resolution.
• Establish and enforce data standards, naming conventions, and controlled vocabularies; influence organizational best practices in regulatory operations and systems.
• Oversee end-to-end submission planning and tracking activities within Veeva RIM, ensuring accurate and timely submission timelines, milestones, and health indicators.
• Design, implement, and maintain standard operating procedures (SOPs) and work instructions for Regulatory Operations.
• Lead process harmonization and standardization across programs and regions.
• Monitor KPIs and metrics related to submission performance, cycle times, and system utilization.
• Support cross-functional teams in understanding and utilizing regulatory systems and processes.
• Contribute to governance forums, project teams, and business transformation initiatives as required.
• Support change management initiatives, including training, communications, and adoption strategies.

• Depending on experience and need, may be assigned other regulatory or operational projects within the Regulatory Affairs
• This position requires approximately 10% travel.

Supervisory Responsibilities:

This position may be responsible for assisting with the oversight of vendors and/or contractors.

Interactions:

This position partners closely with Regulatory Affairs, Clinical, Quality, Pharmacovigilence and cross-functional stakeholders.

Qualifications

Education and Experience:

• Bachelor's Degree in life sciences or related field.
• 8+ years of experience in Regulatory Operations within pharma/biotech.
• Demonstrated experience with global regulatory submission planning, tracking and lifecycle management.
• Deep hands-on expertise and strong knowledge in Veeva RIM functionalities and workflows.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills and Abilities:

• Solid understanding of the clinical development process and regulatory requirements within the pharmaceutical industry, including regulatory submission pathways (e.g., IND, NDA, BLA, MAA) and lifecycle management activities.
• Demonstrated experience in submission planning, tracking, and portfolio reporting, with knowledge of regulatory data governance and compliance standards.
• Experience supporting global regulatory strategies and multi-region submissions.
• Proficient in Microsoft Word, Excel, and PowerPoint, with effective written and verbal communication skills in English.
• Familiarity with project management principles and tools (e.g., Microsoft Project, Smartsheet).
• Experience managing cross-functional projects in a pharmaceutical development environment.
• Ability to develop and deliver training, supporting adoption of systems and processes.
• Exposure to process improvement methodologies (e.g., Lean, Six Sigma) is advantageous.
• Analytical capabilities with the ability to utilize RIM data to inform insights and decision-making.
• Strategic perspective combined with effective operational execution.
• Problem-solving mindset with a focus on continuous improvement.
• Contributes to improved transparency and reporting of regulatory activities.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

Work Environment:

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

Benefits

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

Pay Transparency

The base pay range for this role is $141,000 per year to $194,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.