Job Description:Director, Global Regulatory Affairs
Location: Remote (USA)
Company: NewAmsterdam Pharma
Reports To: Head of Regulatory Affairs
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.
