Regulatory Manager

Jobgether

2d • $106,000 - $151,000 • Remote

About The Position

This Regulatory Manager role is a critical position for ensuring compliance and strategic guidance throughout the clinical development lifecycle. You will provide regulatory expertise for clinical trials, preparing high-quality submissions to regulatory authorities and ethics committees while ensuring alignment with applicable laws and guidelines. The role requires active collaboration with project teams, leadership, and cross-functional stakeholders to deliver efficient and compliant regulatory strategies. You will monitor evolving regulations, advise on their impact, and maintain regulatory intelligence to support organizational objectives. This position offers a dynamic environment with opportunities to lead projects, guide junior staff, and contribute to process improvements on a global scale.

Requirements

• Bachelor’s degree in a scientific or healthcare discipline; graduate or postgraduate degrees preferred.
• 5+ years of regulatory affairs experience in pharmaceutical or CRO environments.
• Strong knowledge of drug development processes, clinical trial methodology, and regional regulatory requirements (US, EU, or other major markets).
• Experience preparing submissions to regulatory authorities, including INDs/CTAs, amendments, scientific advice procedures, and post-approval filings.
• Ability to interpret clinical and pre-clinical data to inform regulatory strategy.
• Excellent organizational, interpersonal, and communication skills, including presenting to diverse audiences.
• Competence in managing multiple tasks, problem-solving, and prioritizing workloads in a fast-paced environment.
• Willingness to travel domestically and internationally as needed.
• Proficiency in MS Office/Office 365 and fluency in English; additional language skills are a plus.

Responsibilities

• Provide regulatory guidance throughout the clinical development lifecycle, ensuring compliance and high-quality submissions.
• Compile, review, and coordinate regulatory documents including INDs/CTAs, annual reports, amendments, and marketing applications.
• Serve as the representative of regulatory affairs in project meetings with internal teams and external stakeholders.
• Lead or contribute to regional and global projects, overseeing regulatory specialists to achieve submission goals.
• Maintain regulatory trackers, project plans, and intelligence tools to keep leadership informed and ensure process consistency.
• Support professional development of regulatory and operational staff and contribute to quality initiatives.
• Advise on regulatory strategy, timelines, and submissions while providing ICH GCP guidance and training.

Benefits

• Competitive salary range ($106,000—$151,000 USD, depending on location).
• Eligibility for discretionary annual bonus and equity participation where applicable.
• Comprehensive health, dental, vision, and life insurance coverage.
• Retirement savings plan with company contributions.
• Paid time off, sick leave, parental leave, and holidays.
• Opportunities for professional growth and leadership development.
• Flexible, remote-capable work environment with a collaborative, high-impact culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level