Director/ Senior Director, Regulatory CMC
$200,000–$200,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Lead Regulatory CMC strategy for telitacicept, acting as the Regulatory CMC Lead for assigned programs to provide strategic guidance on complex regulatory topics. Negotiate with regulators for initial INDs/CTAs, amendments, and future marketing registration applications while establishing and executing high-quality CMC submissions. Communicate CMC regulatory requirements to ensure development activities follow applicable guidelines and manage change control, inspection management, and vendor relationships. Author regulatory documents and provide guidance on CMC reports, while maintaining responsibility for all CMC regulatory timelines.
Required Qualifications
- Extensive experience in the development of biologics and combination biologic/device products
- Strong scientific background and training in manufacturing processes and development and development of combination biologic/device products
- Experience working with FDA sCDER
- A strong background & track record in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of biologic medicinal products
- A broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution in US/ex-US
- Experience interfacing with FDA, and other global health authorities
- Demonstrated risk identification and critical thinking skills
- Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities in biologics
- Ability to interact effectively across all levels of the organizations; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives
- Recognized as an influential leader who possesses a cross-functional collaborative skill set
- Strong oral and written communication skills with strong attention to detail and the ability to coordinate multiple activities in a faced paced biotech environment
- Able and willing to author regulatory documents as needed and provide guidance to subject matter experts on authoring regulatory appropriate CMC reports and assessments
Desired Qualifications
- PharmD or PhD preferred
- ≥8 years of industry experience in Regulatory CMC biologics
- Small molecule and medical device experience
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