Associate Director, Regulatory Project Manager Contractor

Bayside Solutions; California (MO); On-site; USD 118,000 - 132,000; Full time

Job summary

Bayside Solutions is seeking an Associate Director, Regulatory Project Manager Contractor to drive regulatory timelines from IND/CTA through BLA/NDA/MAA, coordinating cross-functional teams and external vendors to maintain on-time, compliant submissions.

The role emphasizes risk anticipation, strategic resourcing, and collaboration with Regulatory Affairs, Medical Writing, and project SMEs to advance neurodegenerative therapy programs.

Qualifications

• Typically requires 12+ years of related experience with a Bachelor's degree; or 10+ years with a Master's; or 7+ years with a PhD; or equivalent experience, plus 5+ years of project/program management experience.
• Experience leading regulatory project management across INDs/CTAs and marketing applications; rare disease/complex filing preferred.
• Proficiency in Smartsheet or comparable project/resource management software.
• Ability to lead cross-functional teams and influence senior stakeholders without direct authority.
• Strong track record identifying risk proactively and driving resolution across ambiguous, multi-stakeholder problems.

Responsibilities

• Leads development and management of regulatory activity timelines across the portfolio, including regulatory documents, health authority interactions, and submissions.
• Partners with Regulatory Program Managers and Program Directors to align regulatory timelines with corporate and program-level goals.
• Manages external partnerships with vendors.
• Drives timely delivery from cross-functional SMEs and unblocks complex issues without a standard playbook.
• Supports cross-functional health authority interaction and filing team needs, owning risk identification and timeline impact assessment.
• Owns regulatory timeline templates and resourcing models for long-range and annual budgeting.
• Drives regulatory initiatives and represents Regulatory Affairs on cross-functional initiatives.
• Mentors junior regulatory project management staff.

Skills

Cross-functional leadership

Risk identification

Program management

Project management

Vendor management

Education

Bachelor's degree in related field

Master's degree in related field

PhD

Tools

Smartsheet

Job description

Associate Director, Regulatory Project Manager Contractor

W2 Contract

Pay Rate: $86 - $96 per hour

Job Summary:

This role drives the operational backbone of our regulatory strategy, ensuring that every drug candidate's path from IND/CTA through BLA/NDA/MAA stays on track, on time, and aligned across functions. Acting as a trusted cross-functional partner to Regulatory Program Managers, Medical Writing, Regulatory Operations, and development SMEs, this individual anticipates risk before it becomes a delay and translates complex, shifting priorities into clear, actionable plans. The role shapes how Regulatory Affairs plans and resources its work, contributing directly to our ability to bring novel therapies for neurodegenerative disease to patients faster.

Duties and Responsibilities:

• Leads development and management of regulatory activity timelines across the portfolio, spanning regulatory documents, health authority interactions, and submissions, anticipating downstream risk and adjusting strategy as program priorities shift.
• Partners with Regulatory Program Managers and Program Directors to align regulatory timelines with corporate and program-level goals, resolving competing priorities across programs.
• Manages external partnerships with vendors
• Drives timely delivery from cross-functional SMEs, applying judgment to unblock complex, ambiguous issues that don't have a standard playbook.
• Supports cross-functional health authority interaction and filing team project needs, owning risk identification, mitigation planning, and timeline impact assessment in partnership with Filing Team/Health Authority Interaction Leads.
• Owns regulatory timeline templates and resourcing models, shaping Regulatory Affairs' long-range and annual budget forecasting.
• Drives regulatory initiatives and/or represents Regulatory Affairs on strategic cross-functional initiatives
• Mentors and provides technical direction to junior regulatory project management staff on complex filings, without formal supervisory responsibility.

Requirements and Qualifications:

• Typically requires a minimum of 12 years of related experience with a Bachelor's degree; or 10 years and a Master's degree; or a PhD with 7 years of experience; or equivalent experience, and 5+ years of project/program management experience.
• Typically requires demonstrated experience leading regulatory project management across INDs/CTAs and marketing applications; rare disease and/or complex filing experience preferred.
• Proficiency in Smartsheet or comparable project/resource management software.
• Demonstrated ability to lead cross-functional teams and influence senior stakeholders without direct authority.
• Strong track record identifying risk proactively and driving resolution across ambiguous, multi-stakeholder problems.

Desired Skills and Experience Regulatory Project Management, Regulatory Affairs, Regulatory Strategy, Global Regulatory Submissions, INDs, CTAs, BLAs, NDAs, MAAs, Marketing Applications, Health Authority Interactions, Regulatory Documentation, Submission Planning, Portfolio Timeline Management, Program Management, Cross-Functional Leadership, Filing Team Coordination, Vendor Management, Risk Identification, Risk Mitigation, Timeline Impact Assessment, Resource Planning, Budget Forecasting, Regulatory Operations, Strategic Initiatives, Stakeholder Management, Team Mentoring, Smartsheet, Rare Disease, Complex Filings

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.