Senior Regulatory Affairs Lead - Remote Global Submissions

NewAmsterdam Pharma Company; Northern (KY); Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Retirement plans

Long-term incentives

Job summary

NewAmsterdam Pharma seeks a Senior Manager of Global Regulatory Affairs to drive regulatory strategy, guidance, and submissions for late-stage programs. You will interact with global health authorities, manage vendor relationships, and ensure timely regulatory filings while maintaining high scientific standards.

You will lead cross-functional teams across clinical development, CMC, and quality to address regulatory challenges in a fast-paced environment and contribute to lifecycle management

Qualifications

• Advanced degree (Ph.D., Pharm.D., or M.S.) in life sciences, regulatory affairs, or a related field.
• 7+ years of regulatory affairs experience (or combination of regulatory, clinical development, medical writing, or related experience) in the pharmaceutical industry, with a strong focus on clinical-stage development.
• Experience supporting regulatory submissions, including INDs, CTAs, and/or MAAs and NDAs.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory pathways for drug development.
• Ability to work cross-functionally in a fast-paced, evolving environment.
• Excellent communication, collaboration, and problem-solving skills.

Responsibilities

• Support the development and implementation of regulatory strategies for clinical development programs, ensuring alignment with business objectives.
• Contribute to the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs) and support regulatory interactions with global health authorities.
• Provide regulatory guidance to internal stakeholders on clinical trial design and labeling requirements.
• Stay up to date with evolving regulatory requirements and ensure company practices remain compliant with FDA, EMA, and ICH guidelines.
• Support the compilation and review of regulatory documents, ensuring scientific integrity and compliance.
• Collaborate with clinical, CMC, and quality teams to proactively address regulatory challenges and expedite drug development timelines.
• Manage relationships with external vendors (consultants and CROs) involved in clinical trials and regulatory submission activities.
• Monitor vendor performance and address any issues or delays to ensure that regulatory milestones are met on time and within budget.

Skills

Regulatory strategy

Regulatory submissions

FDA regulations

ICH guidelines

Cross-functional collaboration

Vendor management

Lifecycle management

Education

Advanced degree (Ph.D./Pharm.D./M.S.) in life sciences/regulatory affairs

Job description

NewAmsterdam Pharma seeks a Senior Manager of Global Regulatory Affairs to drive regulatory strategy, guidance, and submissions for late-stage programs. You will interact with global health authorities, manage vendor relationships, and ensure timely regulatory filings while maintaining high scientific standards.

You will lead cross-functional teams across clinical development, CMC, and quality to address regulatory challenges in a fast-paced environment and contribute to lifecycle management