Regulatory Affairs & Customer Relations Assoc

SUMMARY:

The role of a Regulatory Affairs / Customer Relations Associate is to support in the timely planning and coordination of regulatory projects, customer relations activities and reporting. This individual will provide support with 3rd party inspections, site registrations and updates and external market trade requirements.

Essential Duties and Responsibilities: include the following. Other duties may be assigned.

• Reviews, evaluates, and communicates (internally and externally) on all customer complaints.
• Conducts clarification communication with both end customer and customers regarding the received complaints.
• Summarizes, trends, and develops summary action plans for the customer complaints.
• Champions and participates in RCA activities regarding received customer complaints.
• Completes, documents and follows-up on action items from the 8D process.
• Works closely with the Quality Control team to gather data and supports with investigations related to customer complaints.
• Generates customer complaint event reports as required by applicable laws and regulations.
• Participates in activities to prepare for FDA audits, APHIS inspections and other regulatory inspections as needed.
• Monitors federal and state legislative changes, new guidance documents, and EPA review activities related to products and communicates internally.
• Maintains an electronic file, as well as paper files, for all government filings and documents.
• Reviews APHIS International Regulations (iREGS) for Animal Product Exports to ensure site readiness for product export.
• Supports with the preparation, including writing as necessary, assembling, reviewing, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
• Ensures customers’ products are registered at the state level at the required registration intervals.
• Participates in the review of product / packaging labels and navigating the affected components through the approval process.
• Performs other duties as assigned.

Supervisory Responsibilities:

Not Required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

• BS degree in technical, scientific, or business-related discipline that stresses excellent communication and writing skills desired.
• Prior work experience with reference to customer relations handling.
• Prior work experience with reference to regulatory experience (working on emerging markets preferred but required).
• Limited experience on product label reviews.
• Strong planning and organizational skills.
• Attention to detail.
• Ability to be flexible to meet business needs.
• Professional approach and attitude a plus.
• Ability to work in SAP a plus but not required.

Computer and Technology Skills:

• Proficient with MS Office Suite

Language Skills:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedural manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization. German language speaking skills is another advantage.

Mathematical Skills:

Ability to work with mathematical concepts such as probability and statistical inference, and ability to apply concepts such as: fractions, percentages, ratios and proportions to practical situations.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to use hands to finger, handle, or feel and reach with hands and arms. The employee is required to stand, walk, sit, and talk and hear. The employee must regularly lift and / or move up to 15 pounds, frequently lift and / or move up to 30 pounds and occasionally lift and / or move up to 50 pounds. Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Allergen Awareness

Products produced in this facility may contain the following allergens: Egg, Shellfish, Fish, Gluten.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Job descriptions are not intended to create a contract, nor are they to be construed to constitute contractual obligations of any kind or a contract of employment between Saturn Petcare Inc. and any of its employees. The provisions of job descriptions have been developed at the discretion of management and may be amended or cancelled at any time by Saturn Petcare Inc. with or without notice.

Employment with Saturn Petcare Inc. is voluntarily entered into, and the employee is free to resign at will at any time, with or without cause. Similarly, Saturn Petcare Inc. may terminate the employment relationship at will at any time, with or without notice or cause, so long as there is not violation of applicable federal or state law.