New · posted Oct 15
NewAmsterdam Pharma · Biotechnology
Director, Global Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
The Director, Regulatory Affairs, will regulatory leadership across assigned programs, with a focus on regulatory strategy, submissions, compliance, and lifecycle management. This role involves significant interaction with internal cross-functional teams as well as external vendors to ensure the timely and successful completion of regulatory filings. The Director will also take responsibility for managing relationships with external consultants and contractors, ensuring that deliverables meet regulatory and quality standards. The ideal candidate will have strong regulatory affairs expertise, experience managing external resources, and a proven ability to act within a cross-functional teams. Key to this role is the ability to balance rigorous attention to detail with a strategic, big-picture perspective, recognizing how individual regulatory decisions may impact the overall development program.
Company: NewAmsterdam Pharma
Reports To: Head of Regulatory Affairs
NewAmsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk for heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the world’s preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity.
What you need
Advanced degree (Ph.D., Pharm.D., or M.S.) in life sciences, regulatory affairs, or a related field.
10+ years of regulatory affairs experience pharmaceutical industry, with a strong focus on clinical-stage development.
Proven track record of leading 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, leadership, and strategic problem-solving skills.
NAP has adopted an on-demand workplace philosophy. This remote role requires in-person attendance at the NAP office in the Philadelphia area based on business needs and work requirements rather than a set office schedule.
What you'll do
Develop and implement regulatory strategies for clinical development programs, ensuring alignment with business objectives.
Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs) and manage regulatory interactions with global health authorities.
Provide strategic regulatory guidance to internal stakeholders on clinical trial design and labelling requirements.
Stay up to date with evolving regulatory requirements and ensure company practices remain compliant with FDA, EMA, and ICH guidelines.
Oversee 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.
Oversee and manage relationships with external vendors (consultants and CROs) involved in clinical trials and regulatory submission activities. Ensure that vendor deliverables meet regulatory requirements, quality standards, and project timelines.
Monitor vendor performance and address any issues or delays to ensure that regulatory milestones are met on time and within budget.
Pay and benefits
NewAmsterdam Pharma didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Competitive base salary
Annual bonus
Long-term incentives
Health insurance
Dental and vision coverage
Term life and disability coverage
Working conditions
Location: Remote (USA)
Equal opportunity, accessibility and legal noticesNewAmsterdam Pharma's statements, word for word
We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $209,500 | $235,000 | $264,000 |
Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not NewAmsterdam Pharma's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Regulatory submissions4
- GMP and compliance3
- Documentation and SOPs3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
NewAmsterdam Pharma on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Regulatory3 100%
By level
- VP & Executive1 33%
- Director1 33%
- Manager1 33%
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Director, Global Regulatory Affairs at NewAmsterdam Pharma
Open until filled.