Job Description:Senior Manager, Global Regulatory Affairs
Location: Remote (USA)
Company: NewAmsterdam Pharma
Reports To: Senior Director, Regulatory Affairs
Position Overview: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.
Key Responsibilities:
- 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.
Qualifications:
- 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
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.
