Note: The job is a remote job and is open to candidates in USA. Bayside Solutions is seeking an Associate Director, Regulatory Project Manager Contractor to drive the operational backbone of regulatory strategy for drug development programs. The role manages regulatory timelines, coordinates cross-functional teams and vendors, identifies and mitigates risks, supports health authority interactions and filings, and contributes to resource and budget planning.
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
Skills
- • 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
- • 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
- Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate
- Rare disease and/or complex filing experience preferred
Benefits
- Remote role
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