Job Summary

The Regulatory Affairs Specialistprovides leadership support to the Regulatory Affairs Manager and professional expertise to other key stakeholders in all regulatory matters to ensure continuous success in attaining business objectives of CJ America Inc.

The individual in his role will have in-depth experience in regulatory affairs including supporting the submission of regulatory documents, ensuring compliance with applicable laws and regulations, and working with cross-functional teams to drive product development and market access. This role is essential for ensuring that our products meet regulatory requirements throughout their lifecycle.

Success in this position requires strong organizational, analytical, technical, and effective communication skills to help develop and implement the strategic business goals of CJ America Inc.

Job Description and Responsibilities

· Represent the organization before domestic and international agencies on major policy matters or critical decisions regarding company products.

· Work alongside Regulatory Affairs Manager and provide response to regulatory agencies regarding product information or issue resolution.

· Manage external auditing program for both human and animal food facilities; conduct audits of distribution centers and other facilities applicable to the Foreign Supplier Verification Program and oversee agency inspections and product recalls.

· Provide extended regulatory support for CJ America Inc. sales operation for human nutrition and animal nutrition businesses. (FNT and ANH).

· Work collaboratively with CJ Headquarters Regulatory Solution Team, technical, manufacturing, quality, and sales operations to complete accurate customer questionnaires in a timely manner.

· Develop relationships with state and federal regulatory agencies to familiarize and analyze the potential impacts of proposed regulations while identifying and interpreting relevant regulatory guidelines.

· Monitors emerging trends regarding industry regulations to determine potential impacts on organizational processes.

· Provides key regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products and communicates regulatory information to multiple departments and ensures that information is interpreted correctly.

· Participate in preparation and submission of regulatory agency applications – FDA GRAS Notice, CFIA, AAFCO, FEMA, NDIN -FDA and correspondence with regulatory authorities, consultants, technical and R&D team.

· Actively contribute to developing regulatory strategies and implementation plans for the preparation and submission of new products.

· Direct management and full accountability for Feed State License and Tonnage Report Program.

· Implement and monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.

· Monitor department KPIs and assisting RA Manager in maintaining monthly and annual budget, establish regulatory priorities and allocating resources and workloads.

· Responds to high volume of incoming customer requests - completes requests for standard documents, questionnaires, and customer requirements and provide customer correspondence in response to standard inquiries and oversee documentation efforts to ensure compliance with domestic and international regulations and standards.

· Organize and maintain all regulatory and quality documentation, standard correspondence, and tracking responses to customer inquiries. Assembles and releases documentation in a timely and confidential manner while manage and maintain hard and digital copies of CJ America Inc. Regulatory Department records and database.

· Report any discrepancies on CJ Quality programs, processes & procedures, documentation to ensure the quality, integrity and regulatory compliance of manufactured products and services ensuring compliance of all local, state and federal regulations for human and animal food.

· Responsible for overall management of Foreign Supplier Verification Program (FSVP) based on FSMA guidelines.

· Monitor animal and human food safety requirements which includes but is not limited to legislative mandates, changes in certification requirements, FDA/EPA/USDA/CBP/CFIA mandates, etc. and ensures corporate activities are aligned with corporate sustainability.

· Performs other duties as assigned.

Supervisory Responsibilities

· None

Job Qualifications, Education and Experience:

- Bachelor’s degree in business or science related field required

- Food Science, Regulatory, Quality Control, Biology or related science field highly preferred,

- 5 Years of directly related experience required

OR

- Master’s degree & 2 years of directly related experience preferred

- Travel: Up to 5% travel may be required for this position.

Required Skills, Knowledge and Abilities

· Strong organizational skills and ability to prioritize multiple assignments.

· Leadership skills with critical thinking and ability to apply it practically.

· Strong analytical, problem solving and risk-management perspective.

· Exhibits high level of professional demeanor both internally and externally that reflects positive work aptitude, adheres to the company’s and departmental policies and practices confidentiality.

· Excellent verbal and written communication skills with attention to detail with specific proficiency in documentation review and proof-reading required.

· Excellent time management skills: ability to handle multiple requests/priorities at a time and complete assigned requests accurately and on a timely basis.

· Motivation to learn and acquire a good working knowledge of essential skills for effective job performance including learning federal, industry regulations and quality systems as well receiving professional training and certifications.

· Excellent computer skills, i.e. Microsoft Outlook, Word, Excel, Adobe, Etc.

· Strong analytical, problem solving, critical review/thinking and (from risk-management perspective), and multi-tasking skills.

· Knowledge of the FDA Food Safety Modernization Act, Foreign Supplier Verification Program, FD&C Act, Association of America Feed Control Officials. Food Import Regulations, cGMP experience, HACCP certification and GFSI training, root cause analysis and CAPA.

CJ America Bio participates in E-Verify.