Senior Manager, Global Regulatory Affairs

NewAmsterdam Pharma Company; Northern (KY); Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Retirement plans

Long-term incentives

Job summary

NewAmsterdam Pharma seeks a Senior Manager of Global Regulatory Affairs to drive regulatory strategy, guidance, and submissions for late-stage programs. You will interact with global health authorities, manage vendor relationships, and ensure timely regulatory filings while maintaining high scientific standards.

You will lead cross-functional teams across clinical development, CMC, and quality to address regulatory challenges in a fast-paced environment and contribute to lifecycle management

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.

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 labeling 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.
• Monitor vendor performance and address any issues or delays to ensure that regulatory milestones are met on time and within budget.

Skills

Regulatory strategy

Regulatory submissions

FDA regulations

ICH guidelines

Cross-functional collaboration

Vendor management

Lifecycle management

Education

Advanced degree (Ph.D./Pharm.D./M.S.) in life sciences/regulatory affairs

Job description

## Senior Manager, Global Regulatory AffairsApply: Remote - USA: Full time: Posted 5 Days Ago: R-100092**Job Description:**Senior Manager, Global Regulatory Affairs**Location:** Remote (USA)**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.**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. 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.