Senior Manager, Regulatory Affairs

For a leader in the Pharmaceuticals & Biotech space, this role provides business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations, strengthening responsible execution, improving decision-making, and supporting sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Plan and manage regulatory activities for complex projects with minimal supervision
• Develop strategies for expedited approvals of regulatory submissions
• Oversee writing, assembling, reviewing, and submitting regulatory dossiers domestically and internationally
• Ensure compliance of regulatory submissions and manage the preparation of meeting requests
• Supervise the compilation and submission of INDs, BLAs/NDAs, and safety reports, providing regulatory expertise to project teams
• Maintain up-to-date regulatory knowledge and compliance within the department

Qualifications

• 7+ years' experience in regulatory affairs with a BA/BS degree
• Expertise in preparing INDs and familiarity with NDAs, amendments, and supplements
• Proficient in CTD/eCTD formats and Adobe Acrobat Professional
• Strong knowledge of FDA and ICH regulations, with understanding of FDA structure
• Working knowledge of GMP, GLP, and GCP regulations relevant to the pharmaceutical lifecycle
• Excellent communication and planning skills, detail-oriented and self-motivated

Benefits

• Medical, Dental, and Vision coverage
• 401(k) plan with company contributions
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options
• Life Insurance and Paid Time Off (PTO)
• Wellness programs and employee stock purchase options

Pay

$139,800 – $184,800 annually