Shape and lead regulatory strategies for an innovative pipeline of first-in-class small-molecule medicines, providing strategic regulatory leadership across clinical development from Phase 2 through registration and lifecycle management.
Compensation
Annual salary ranging from $220,000 to $250,000.
Responsibilities
Provide regulatory leadership for clinical-stage assets through Phase 2 and subsequent development stages, establishing global regulatory and registrational strategies.
Independently develop and execute innovative regulatory strategies across the portfolio, including clinical development and product lifecycle management.
Lead the preparation, review, and submission of regulatory documentation, including INDs, CTx applications, briefing documents, Investigator's Brochures, NDAs, DMFs, IMPDs, and other required materials.
Identify regulatory submission gaps, assess potential risks, and develop practical mitigation strategies to support successful development and registration.
Represent the organization in interactions and negotiations with global health authorities, including the FDA, EMA, and Health Canada.
Support and lead global regulatory activities for an innovative oncology therapeutic throughout its clinical development and commercialization preparation.
Compensation
Annual base salary range of $168,000–$198,000 USD.
Potential eligibility for bonus compensation, stock awards, and other variable compensation.
Responsibilities
Provide scientific and biological regulatory guidance to project teams and clinical study sub-teams
Develop and implement global regulatory strategies for the investigational therapy
Independently manage regulatory activities at the molecule and clinical study levels, including Clinical Trial Applications (CTAs) and Investigational New Drug (IND) submissions
Review and approve investigator document packages and related FDA submissions
Interpret applicable government regulations and scientific guidance to address regulatory requirements throughout clinical development
Requirements
Bachelor's degree in Biotechnology, Biological Sciences, or a related field
MS or PhD or PharmD (preferred)
Nice to have: CRO experience on ex-US CTA submissions
The Regulatory Affairs Manager ensures compliant market access for diverse portfolios (medicines, devices, cosmetics, foods) by leading product registration, labeling, and claims aligned with commercial goals. They maintain ongoing compliance, manage health authority interactions, and oversee submissions and inspections.
Responsibilities
Lead the end-to-end regulatory process for new product launches and lifecycle maintenance (NPD & Line Extensions), utilizing systems like Veeva Vault to prepare dossiers, secure registrations, and ensure compliant labeling and claims aligned with commercial plans.
Develop robust regulatory strategies (e.g., RSD) and conduct gap analyses to identify risks early; proactively manage the impact of regulatory changes and propose solutions to ensure products are scientifically robust and legally compliant.
Act as a strategic partner to Marketing, Sales, Supply Chain, and QA teams, embedding regulatory requirements into business processes (e.g., Quality Agreements, TTS); maintain SOPs and compliance databases to drive operational efficiency.
Serve as the primary point of contact for Health Authorities and industry bodies, managing inspections, responding to queries, and building strong relationships to facilitate smooth approvals and negotiations.
Monitor global and local regulatory landscapes (including e-commerce and sustainability trends), analyze impacts on the portfolio, and establish robust safety review processes to ensure product integrity and compliance.
