Director, Global Regulatory Affairs

NewAmsterdam Pharma Corporation; United States; Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Term life and disability coverage

Retirement plans

Job summary

NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs to lead regulatory strategy, submissions, and lifecycle management for clinical programs. The role requires cross-functional collaboration with internal teams and external vendors to ensure timely regulatory filings and alignment with global guidelines.

The ideal candidate has 10+ years of regulatory affairs experience, a proven submissions track record, and deep knowledge of FDA/ICH pathways.

Qualifications

• 10+ years of regulatory affairs experience in pharmaceutical industry.
• Proven track record of leading regulatory submissions (INDs, CTAs, MAAs, NDAs).
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory pathways.

Responsibilities

• Develop and implement regulatory strategies for clinical programs, aligned with business objectives.
• Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs) and manage interactions with health authorities.
• Provide strategic regulatory guidance to internal stakeholders on trial design and labeling requirements.
• Stay updated with evolving regulations and ensure compliance with FDA, EMA, ICH guidelines.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges and expedite timelines.
• Oversee management of external vendors (consultants, CROs) and ensure deliverables meet requirements.

Skills

Regulatory strategy

Cross-functional leadership

Vendor management

FDA/ICH knowledge

Education

Ph.D., Pharm.D., or M.S. in life sciences

Job description

Job Description:

Director, Global Regulatory Affairs

Location: Remote (USA)

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.

Position Overview:

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.

Key Responsibilities:

• 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.

Qualifications:

• 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.

Salary and Benefits:

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.