Associate Regulatory Scientist
April 29, 2021
Pay Type Salaried State: IN City: Evansville Area of Interest: Research & Development Exempt or Non-Exempt: Exempt Requisition Number 1473 Job Title Associate Regulatory Scientist Job Description
Swedish Match North America LLC, a manufacturer and marketer of well-known tobacco products, non-tobacco ZYN pouch products, as well as complementary products, is currently seeking an Associate Regulatory Scientist for the R&D Compliance & Risk Management department at the Owensboro, KY facility.
• Responsible for the regulatory compliance of Company Products marketed and sold in North America, and other regions, including FDA reporting obligations.
• Submits regulatory filings under guidance of department Director.
• Works with department managers to ensure compliance with regulations.
• Responsible for development and maintenance of product life cycle data & document management.
• Assists with the daily operations of the regulatory department and helps ensure compliance with all relevant tobacco regulations.
• Works closely with Legal, Product Development, Marketing and colleagues in Swedish Match Scandinavian R&D organization on interpretation and timely execution of regulatory requirements and submissions.
EDUCATION: Bachelor's degree or equivalent experience is required, preferably in a related field such as science, engineering or communications.
EXPERIENCE: Experience in regulatory/quality compliance (FDA or ISO) is highly desired. Working primarily in consumer-packaged goods compliance capacity or working on pharmaceutical compliance and regulatory matters.
SKILL: Ability to analyze complex regulations and ensure that company products and processes are in compliant with those regulations. Proficient in use of computer system software such as MS Word, Excel, Access, Outlook, SharePoint, and PowerPoint. Proficiency in correct English usage, grammar, and punctuation. Exemplary interpersonal skills including ability to work effectively as part of a team across organizational structure as well as the ability to work independently. Excellent organizational skills and attention to detail a must. Effective at multi-tasking. Ability to manage multiple projects simultaneously and meet deadlines. Excellent time management skills - must demonstrate the ability to work independently, with strict deadlines imposed by governmental agencies. Must have degree of initiative, judgment, discretion and confidentiality in performing responsibilities.
KNOWLEDGE: Understanding of federal and state regulatory bodies and processes. Maintain working knowledge and understanding of existing and emerging tobacco regulations. Thorough knowledge of product regulations, enforcement and industry practice relevant to the tobacco industry. Understanding of FDA regulations, submissions and audit procedures and EPA requirements. Knowledgeable in the areas of statistical analysis, toxicology, chemistry, instrumental analysis, microbiology, computer technology, project management, manufacturing, GLP, GMP, regulatory compliance, QA procedures and clinical trials. Knowledge of toxicology and routes of entry, and how chemicals may specifically interact with the human body and with biological organisms is desirable.
OTHER : Must be able to work effectively with others at various levels within the organization and with external contacts. Must be able to provide accurate and timely reports. Ability to sit for long periods of time in an office environment, training room, or meeting setting. Ability to perform data entry using keyboard and/or mouse as well as constant and close visual work at desk or computer. Must have good leadership qualities and provide positive work environment. Must be able to inspire and motivate others. Must be passionate about Business Development goals and objectives.
Benefits for New Hires:
Swedish Match offers competitive salaries, flexible benefits program, medical, dental, and vision, life insurance, paid bonding leave, tuition reimbursement, matching 401(k), paid vacation, 11 paid holidays...and more!
An Equal Opportunity Employer M/F/Disability/Vet