We are LOTTE Biologics! A new company, built on 80 years of tradition!

We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

We deliver therapies that make a Healthier World!

To help us meet our mission LOTTE Biologics is in need of a Sr Manager, Regulatory Affairs to provide regulatory expertise through all stages of the product lifecycle, including development of CMC strategy. This role also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for the site, oversees the TSE/BSE program, and provides compliance documents to support Health Authority submissions.  

• Provide strategic CMC regulatory expertise for project teams from development through completion of post-marketing commitments.
• Guide the development and finalization of the analytical control strategy, including release and stability specifications
• Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success.
• Manage the preparation of CMC documents in support of registrational submissions, and lead the technical review of these documents.
• Interface with the US FDA for CMC submissions and CMC-related issues; coordinate responses to inquiries during regulatory review.
• Perform regulatory assessments for manufacturing changes, and provide guidance on regulatory expectations for biological drug substance.
• Oversee TSE/BSE program and provide documentation in support of lot disposition.  
• Collaborate with project teams and provide insight into regulatory health authority expectations, including resolution of technical issues that may impact regulatory submissions, strategy, or success.
• Lead site regulatory surveillance program.
• Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result.
• Manage site manufacturing licenses and certifications, including FDA establishment renewal.
• Maintain the site Drug Master File.
• Respond to client requests for compliance documents to support regulatory submissions and renewals.
• Foster positive relationships with FDA.

• An extensive knowledge and understanding of FDA, EU, ICH, PIC/S and Japanese guidelines and cGMP.
• Must have project management skills with the ability to lead cross-functional problem-solving teams.
• Bachelor’s degree, M.S. or Ph.D. and at least 10 years relevant experience in the bio-pharmaceutical industry, with a minimum of 5 years’ experience in Quality Assurance or related function and increasing cross-functional responsibility. A combination of education and experience will be considered.
• A minimum of 3 years of Regulatory/CMC experience required.
• Experience in a contract development and manufacturing organization (CDMO) environment a plus.
• Supervisory experience preferred.

Specific Knowledge, Skills, Abilities, etc:

• In-depth knowledge and understanding of FDA and international health authority guidelines and federal regulations, with demonstrated ability to successfully apply these to a compliant work output.
• Robust understanding of drug development process and industry standard practices.
• Knowledge of CMC regulatory requirements for advanced therapies and/or biologics during development and post-approval.
• Ability to communicate complex information clearly and concisely.
• Demonstrated knowledge of subject matter related to quality and compliance.
• Ability to create a team based, collaborative environment.
• Ability to shape the culture by demonstrating examples of compliance behaviors and attitudes.
• Display the flexibility, confidence, and decisiveness to effectively establish proper priorities and manage through the dynamic of frequent change.
• Support the corporate culture to promote professional and performance excellence.
• Detail-oriented with a sense of urgency for completing tasks.
• Demonstrate excellent organizational skills and ability to effectively prioritize work.
• Ability to perform tasks completely and independently and complete assignments without detailed direction.
• Excellent communication, technical writing, and computer skills.
• Demonstrated knowledge of a variety of computer software applications in word processing, spreadsheets and database software.
• Technical knowledge related to manufacturing and laboratory testing required.
• Experience with working in/supporting concurrent manufacturing preferred.
• Experience leading cross-functional teams with demonstrated success is required.
• Superior interpersonal skills to facilitate the development of effective partnering relationships with a diverse array of individuals including counterparts in partner groups, peers, and team members.

Work Environment:  

Primarily office space. Occasional exposure to both manufacturing and laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities.  If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today! 

http://www.lottebiologics.com/

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.