New · posted Oct 15
NewAmsterdam Pharma · Biotechnology
Senior Manager, Global Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Manager
Open until filled
The role
The Senior Manager, Regulatory Affairs, will support the development and execution of regulatory strategies for the company’s investigational therapies, with a focus on regulatory submissions, compliance, and lifecycle management. This role will work closely with cross-functional teams and external vendors to support the timely and successful completion of regulatory filings. The Senior Manager will help manage relationships with external vendors, ensuring that vendor deliverables meet regulatory and quality standards. The ideal candidate will have strong regulatory affairs expertise, experience with vendor management, and the ability to contribute effectively within cross-functional teams.
Company: NewAmsterdam Pharma
Reports To: Senior Director, 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.
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.
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
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 labelling 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. Help 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
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $146,750 | $162,500 | $177,750 |
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 leadership6
- Regulatory submissions4
- GMP and compliance3
- Documentation and SOPs3
- Investigations and CAPA1
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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Senior Manager, Global Regulatory Affairs at NewAmsterdam Pharma
Open until filled.