Are you interested in joining a well-established pharmaceutical company that has a broad portfolio of branded and generic pharmaceutical products? Our client is looking for a strong leader, who can develop and implement CMC strategy, while working directly with the senior leadership team.

Apply here or reach out to Jessica Goodman for more information!

Qualifications:

• Bachelor’s degree
• 8+ years of work experience in US FDA regulated pharmaceutical development and manufacturing
• Must demonstrate strong leadership qualities
• Strong background in CMC documentation is preferred

Responsibilities:

• Lead and manage a team of Regulatory Affairs professionals
• Coordinate and review all regulatory submissions of the company including ANDAs and 505(b)(2) NDAs
• Develop and implement regulatory strategies and filings throughout each product’s lifecycle
• Manage regulatory risks and ensure compliance with all applicable regulations
• Ensure regulatory and cross-functional project strategies and submission timelines are in alignment for successful filing and timely approval
• Actively monitor changes in applicable regulatory requirements and industry trends, and proactively identify and propose solutions for potential regulatory challenges
• Author and review departmental SOPs, as well as any other additional SOPs that may impact regulatory affairs