Summary: The Senior Regulatory Specialist will be responsible for providing limited oversight in the Regulatory Affairs Department by gathering, maintaining and filing necessary and various supporting documents, reports, and assisting with special projects. This individual interacts with all levels within the organization to establish support and maintain procedures in the department ensuring compliance of products, which are developed, manufactured and/or distributed. Additional focus will include developing organizational skills, cross training within disciplines as well within department.
Essential Duties and Responsibilities: include the following. Other duties may be assigned.
- Acts as company representative, developing and maintaining positive relationships with both government and state agencies through oral and written communications.
- Participate in establishing regulatory strategies and plans that lead to new product submissions in support of product marketing approvals.
- Develop documentation for submissions for new product or new intended uses for existing products in support of domestic product marketing approvals.
- Participate on product development teams to develop regulatory strategy and determine requirements for submission for new and existing products for modifications to intended use, design, labeling, materials, and manufacturing processes.
- Assist in implementing manufacturing documentation for new products.
- Maintain open communications with regulatory agencies as required.
- Prepare and file premarket submissions.
- Interpret and utilize laws and regulations and provide regulatory advice regarding laws and regulations.
- Review product labeling to assure labels are compliant with labeling and marketing regulations.
- Prepare and maintain regulatory files and tracking databases.
- Prepare, revise, review, and maintain procedures to harmonize regulatory policies and processes.
- Provide effective communication to project teams regarding new regulations, policies and initiatives that could impact products and processes.
- Assist with preparation for and participate in regulatory agency audits.
- Review and approve labeling, product process changes, and product documentation as it pertains to regulatory filings for new and existing products.
- Establish and maintain regulatory data for all ingredients and raw materials based on industry guidelines/restrictions. Review raw material compositions and international regulatory status with global counterparts
Knowledge, Skills and Abilities
Ability to read, analyze, comprehend and apply general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Requires adequate visual acuity to read written documents. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus .
Ability to apply common mathematical concepts such as addition, subtraction, multiplication and division with the need on occasion to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Other Skills and Abilities:
Must be proficient in Microsoft Operating platforms and associated Office suite programs that may include but not limited to Outlook, Word, Excel and Power Point. It is necessary to have above average spelling and grammar along with strong written and verbal communication skills.
Excellent organizational abilities and communication skills.
Minimum of 5 years’ experience in regulatory affairs field preferred.
Ideal candidate will have a strong knowledge of and be familiar with many of the following regulations: EPA, FDA, CVM, AAFCO, NAFTA, DOT, IMDG, IATA, FTC, VOC, CA Prop 65.
Perrigo - 13 months ago
From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading...