Regulatory Manager / Senior Regulatory Manager

Responsibilities

We are representing a confidential clinical research organization seeking a Regulatory Manager or Senior Regulatory Manager for a remote position. In this role, you will provide regulatory strategy and development guidance for clinical trials, coordinate regulatory submissions, and ensure compliance with applicable regulations.

Your responsibilities will include:

• Providing regulatory guidance throughout the clinical development life cycle
• Compiling, coordinating, and reviewing applications to regulatory authorities including CTAs, INDs, annual reports, amendments, scientific advice procedures, orphan designations, and paediatric planning
• Developing and reviewing documents for submission to regulatory authorities and ethics committees to ensure compliance with regulatory standards
• Representing regulatory affairs at project team meetings with external and internal stakeholders
• Leading project teams regionally or globally as needed
• Overseeing and coordinating regulatory affairs specialists to achieve submission targets
• Maintaining project plans, trackers, and regulatory intelligence tools
• Assisting in the development of junior regulatory staff
• Contributing to regulatory strategy and timeline development for new study opportunities
• Participating in corporate quality initiatives across business units
• Staying current with laws, regulations, and guidelines governing drug development and approval
• Providing ICH GCP guidance, advice, and training to clients

What We're Looking For

Minimum Requirements:

• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
• 5+ years of regulatory experience for Manager level; 7+ years for Senior Manager level
• In-depth knowledge of the drug development process, including regulatory milestones
• Specialized knowledge of regulatory activities for at least one major region (EU or US), including submissions such as INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions
• Regulatory affairs experience in a CRO or pharmaceutical industry environment with proven experience leading clinical submissions
• Ability to understand and interpret clinical and pre-clinical study results for regulatory strategy
• Working knowledge of clinical trial methodology, protocols, and study indications
• Expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel, including overnight stays

Key Competencies:

• Strong interpersonal skills and proven ability to contribute to team environments involving multifaceted research activities
• Understanding of financial management
• High degree of professionalism, punctuality, and ability to deliver on commitments
• Ability to manage multiple varied tasks in a fast-paced environment with excellent record-keeping skills
• Self-motivated with ability to work independently and as part of a team
• Capacity to motivate team members to meet timelines and project goals
• Flexible attitude toward work assignments and continuous learning
• Problem-solving skills with ability to prioritize workload and meet deadlines with minimal supervision
• Focus on continuous improvement and process optimization
• Effective communication skills in English, both verbal and written
• Proficiency in conducting formal presentations to diverse audiences

How We Work with You

Get A Job.ai is representing this confidential client in their search for qualified regulatory professionals. When you apply through our platform at getajob.ai, our talent team will review your qualifications and conduct an initial screening. If your background aligns with the role, we will submit your profile to our client for consideration. Please do not attempt to contact the client directly, as all applications must be processed through Get A Job.ai to be considered.

Pay

Compensation details will be discussed during the screening process based on experience level and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to equal opportunity employment. We make hiring decisions without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.