Senior Manager, Global Regulatory Affairs

Jobtailor; Philadelphia (Philadelphia County); On-site; USD 130,000 - 190,000; Full time

Job summary

Jobtailor in Philadelphia, PA, is seeking a seasoned Regulatory Affairs professional to lead strategy for clinical programs and regulatory submissions. The role focuses on INDs, NDAs, CTAs, and MAAs, aligning regulatory plans with business goals.

You will provide regulatory guidance on trial design, labeling, and global development pathways, monitor evolving FDA/EMA/ICH rules, and collaborate with clinical, CMC, and quality teams to drive timely approvals.

Qualifications

• Advanced degree in life sciences or regulatory affairs.
• 7+ years in regulatory affairs within the pharmaceutical industry.
• Strong knowledge of FDA regulations and ICH guidelines.

Responsibilities

• Support development and implementation of regulatory strategies aligned with business objectives.
• Prepare, submit, and maintain regulatory filings including INDs, NDAs, CTAs, MAAs.
• Support regulatory interactions with global health authorities.
• Provide regulatory guidance on trial design and labeling requirements.
• Monitor regulatory requirements and ensure FDA/EMA/ICH compliance.
• Support compilation and review of regulatory documents.
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges and expedite drug development timelines.
• Manage relationships with external vendors, consultants, and CROs.
• Monitor vendor performance and address issues or delays to meet regulatory milestones on time and within budget.

Skills

Regulatory affairs experience

Regulatory submissions (INDs, NDAs, CT

Education

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

Job description

• 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, including INDs, NDAs, CTAs, and MAAs
• Support regulatory interactions with global health authorities
• Provide regulatory guidance to internal stakeholders on clinical trial design and labelling requirements
• Monitor evolving regulatory requirements and ensure company practices remain compliant with FDA, EMA, and ICH guidelines
• Support compilation and review of regulatory documents
• Collaborate with clinical, CMC, and quality teams to address regulatory challenges and expedite drug development timelines
• Manage relationships with external vendors, consultants, and CROs
• Monitor vendor performance and address issues or delays to meet regulatory milestones on time and within budget

Requirements

• 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
• 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

Core Competencies

Demonstrates expertise in regulatory strategies and compliance with FDA, EMA, and ICH guidelines, while effectively collaborating with cross-functional teams to support clinical development and regulatory submissions.

Highest-signal resume keywords

• Regulatory Affairs Experience
• Regulatory Submissions (INDs, NDAs, CTAs, MAAs)
• Knowledge of FDA Regulations
• Clinical Development Expertise
• Cross-Functional Collaboration

Hard Skills

• Regulatory Strategy Development
• Regulatory Filing Preparation
• Clinical Trial Design Guidance
• Regulatory Document Compilation
• Regulatory Compliance Monitoring

Soft Skills

• Excellent Communication
• Collaboration Skills
• Problem-Solving Skills

Certifications & Qualifications

• Advanced Degree (Ph.D., Pharm.D., or M.S.)

Industry Keywords

• Pharmaceutical Industry
• Global Health Authorities
• Vendor Management
• Clinical-Stage Development
• ICH Guidelines