Regulatory Manager

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Manager in the United States.

This role is responsible for ensuring the successful and compliant conduct of clinical trials through strategic regulatory guidance. You will lead the preparation and submission of high-quality regulatory documents, advise project teams on evolving regulations, and help shape regulatory strategies across studies. The position offers a dynamic environment where your expertise impacts both regional and global clinical programs. You will collaborate with cross-functional teams, mentor regulatory specialists, and ensure adherence to corporate quality standards. The ideal candidate is proactive, detail-oriented, and capable of navigating complex regulatory landscapes while providing clear guidance and support to internal and external stakeholders.

• Accountabilities
• Provide regulatory guidance throughout the clinical development lifecycle, ensuring compliance with applicable laws and standards.
• Compile, coordinate, and review submissions to Regulatory Authorities and Ethics Committees, including INDs/CTAs, annual reports, amendments, scientific advice requests, pediatric planning, and marketing applications.
• Develop and review documents intended for regulatory submission, ensuring alignment with regulations and internal quality standards.
• Serve as a representative of Regulatory Affairs in project team meetings and business development discussions, both regionally and globally.
• Oversee and coordinate Regulatory Affairs Specialists to meet submission targets and maintain project plans, trackers, and regulatory intelligence tools.
• Support the development of staff through coaching, guidance, and training initiatives.
• Contribute to regulatory strategy and timelines for new study opportunities, ensuring the highest quality of submitted information.
• 
  
• Requirements
• Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline; graduate or postgraduate education is preferred.
• 5+ years of relevant regulatory affairs experience in pharmaceutical or CRO settings.
• In-depth knowledge of regulatory processes, including submissions to major regions (US/EU), INDs/CTAs, scientific advice, post-approval submissions, and orphan/pediatric designations.
• Strong understanding of clinical and pre-clinical study data, protocols, and indications.
• Knowledge of ICH GCP guidelines, drug development regulations, and regulatory strategy.
• Proficiency in Microsoft Office/Office 365 and other regulatory tracking tools.
• Strong interpersonal, communication, and presentation skills; capable of leading teams and collaborating cross-functionally.
• Ability to manage multiple priorities, work independently, and travel domestically and internationally as required.
• 
  
• Benefits
• Competitive salary range: $106,000—$151,000 USD, with potential discretionary annual bonus.
• Health, dental, and vision insurance, life insurance, and disability coverage.
• Retirement savings benefits (401(k) or equivalent).
• Paid time off, parental leave, and sick leave.
• Professional development and growth opportunities within regulatory functions.
• Collaborative and inclusive work environment with focus on continuous improvement.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.

🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.

📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.

🎯 Based on this analysis, we automatically shortlist the three candidates with the highest match to the role.

🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

By submitting an application to this posting, the applicant acknowledges that Jobgether will process their personal data as necessary to evaluate their candidacy, provide feedback, and, when appropriate, share relevant information with potential employers. Such processing is carried out on the basis of legitimate interest and pre-contractual measures in accordance with applicable data protection laws. The applicant may exercise their rights of access, rectification, erasure, and objection at any time as provided under the GDPR.

#LI-CL1