Regulatory Affairs Manager

Our client is a leading pharmaceutical company of generic products. They are seeking a Regulatory Affairs Manager to join their team!

Salary/Hourly Rate:

$140,000 – $165,000 depending on level of experience

Position Overview:

This Regulatory Affairs Manager role involves overseeing and ensuring the preparation of regulatory submissions for the company. The Regulatory Affairs Manager position offers an experienced professional the chance to join a growing team and be a key collaborator with senior management.

Responsibilities of the Regulatory Affairs Manager:

• Provide leadership and oversight for a team of Regulatory Affairs professionals
• Oversee the preparation, coordination, and review of all regulatory submissions
• Develop and execute regulatory strategies and filings throughout the lifecycle of each product
• Assess and manage regulatory risks while ensuring compliance with all relevant regulations
• Align regulatory and cross-functional project strategies and submission timelines to achieve successful filings and timely approvals
• Stay informed on evolving regulatory requirements and industry trends
• Manage drug product labeling components for all commercial products
• Draft, review, and maintain departmental SOPs, as well as other SOPs affecting regulatory affairs

Qualifications for the Regulatory Affairs Manager:

• Over 7 years of experience in US FDA-regulated pharmaceutical development and manufacturing, including eCTD-format submissions
• Strong expertise in CMC documentation is highly desirable
• Proven leadership abilities, including strategic thinking, decision-making, problem-solving, communication, attention to detail, project management, team building, professional integrity, negotiation skills, adaptability, and stakeholder management
• Excellent communication, interpersonal, organizational and time management skills
• Prior experience in managing personnel is an advantage

Education Requirements:

• Degree in regulatory affairs is preferred
• Bachelor’s degree in chemistry, biology or a related field is acceptable

Benefits:

• Client provided benefits, upon eligibility

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EOE/M/F/D/V/SO