Director, Global Regulatory Affairs

Regulatory Jobs; United States; Remote; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental and vision coverage

Term life and disability coverage

Retirement plans

Zusammenfassung

NewAmsterdam Pharma seeks a Director, Global Regulatory Affairs to provide regulatory leadership across programs, focusing on strategy, filings, compliance, and lifecycle management. You will work with cross-functional teams and manage external vendors to ensure timely regulatory filings and high-quality submissions.

The role requires extensive FDA/EMA knowledge, strong leadership, and the ability to balance detail with a strategic view of development programs.

Qualifikationen

• Advanced degree in life sciences, regulatory affairs, or related field.
• 10+ years regulatory affairs experience in pharma/biotech, clinical-stage.
• Proven track record of leading regulatory submissions (INDs, CTAs, MAAs, NDAs).
• Deep knowledge of FDA, ICH guidelines, and global regulatory pathways.
• Ability to work cross-functional in a fast-paced environment.
• Excellent communication, leadership and strategic problem-solving skills.
• Remote role with in-person attendance at the Philadelphia area office when needed.

Aufgaben

• Develop regulatory strategies for clinical development programs aligned with business objectives.
• Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, CTAs, MAAs) and manage global health authority interactions.
• Provide strategic regulatory guidance on trial design and labeling requirements.
• Stay current with evolving regulatory requirements; ensure FDA/EMA/ICH compliance.
• Oversee compilation and review of regulatory documents with scientific integrity.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges and accelerate timelines.
• Oversee relationships with external vendors (consultants, CROs) for trials and submissions; ensure quality and timelines.
• Monitor vendor performance and address delays to meet milestones on time and budget.

Kenntnisse

Regulatory strategy

Regulatory submissions

FDA/EMA knowledge

Cross-functional collaboration

Strategic problem-solving

Ausbildung

Advanced degree (Ph.D./Pharm.D./MS)

Jobbeschreibung

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-functional 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.