Regulatory Affairs Specialist

CJ America Bio; Downers Grove (IL); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

A prominent food science company is looking for a Regulatory Affairs Specialist to support the Regulatory Affairs Manager in ensuring compliance with regulatory standards. This role involves managing audits, responding to regulatory inquiries, and developing regulatory strategies for product submissions. Candidates should have a relevant bachelor's degree and at least 2 years of experience in regulatory affairs. Strong organizational, analytical, and communication skills are essential, along with knowledge of FDA regulations.

Qualifikationen

• Bachelor's degree in food science, chemistry, biology or related field, master's preferred.
• 2 years of directly related experience preferred.

Aufgaben

• Assist RA Manager in responding to regulatory agencies.
• Develop relationships with state or federal regulatory agencies.
• Identify and interpret relevant regulatory guidelines.
• Manage audits and regulatory agency inspections.
• Participate in preparation of regulatory agency applications.

Kenntnisse

Organizational skills

Leadership skills

Analytical skills

Communication skills

Time management skills

Ausbildung

Bachelor’s degree in food science, chemistry, biology, or related field

Master’s degree preferred

Tools

FDA regulations knowledge

cGMP experience

HACCP certification

Jobbeschreibung

Overview

Regulatory Affairs Specialist provides active support and assists Regulatory Affairs Manager and other key stakeholders in all regulatory matters to ensure continuous success in attaining business objectives of CJ America Inc.

Responsibilities

• Assisting RA Manager and provide responses to regulatory agencies regarding product information or issues. Represent organization before domestic or international regulatory agencies on major policy matters or critical decisions regarding company products.
• Develop relationships with state or federal regulatory agencies to familiarize and analyze the potential impacts of proposed regulations.
• Identify and interpret relevant regulatory guidelines. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• 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.
• Develop and maintain standard operating procedures.
• Direct management and full accountability for Feed State License and Tonnage Report Program.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Monitor department KPIs and assist RA Manager in maintaining monthly and annual budget, establish regulatory priorities and allocating resources and workloads.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability.

Job Qualifications, Education and Experience

• Bachelor’s degree in food science, chemistry, biology, or in related science field, regulatory, master’s degree preferred.
• 2 years of directly related experience (preferred).

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.
• Fast-learning and adaptive to priority shifts and changes in timelines, protocols, software, and business process.
• Exhibits high standard of professional demeanor both internally and externally. 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. Proficiency in documentation review and proof-reading is preferred.
• Excellent time management skills: ability to handle multiple requests/assignments 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.
• 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 are strongly preferred.

Relocation assistance is not available for this role. Candidates must be authorized to work in USA without current or future employer sponsorship.