Associate Director Regulatory Affairs
2 months ago
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
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