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Coordinator International Regulatory Affairs

Upstate Staffing, Inc Anderson, SC
  • Expired: 3 days ago. Applications are no longer accepted.

COORDINATOR, INTERNATIONAL REGULATORY AFFAIRS

1st Shift 8:00 am to 5:00 pm

Pay: $17.00

TEMP TO HIRE *Please review job description fully before applying- applicants will only be considered if they have the relevant experience the client is seeking*

Apply: www.upstatestaffingsc.com

Summary:

The International Regulatory Affairs Coordinator (DOMESTIC AND INTERNATIONAL) is responsible for providing (full) regulatory, technical and administrative support to International Services and other GN International registration and customer services agents. The role will cover, but is not limited to performing activities required to support product registration in several international markets.

Essential Duties and Responsibilities:

STRATEGIC:

· Prepares standard registration documents requested by International Regulatory Affairs (e.gr. certificates of analysis, letters of explanation, raw material summaries, etc.)

· Includes retrieve, compile, proof, publish, submit and maintain archives in audit ready state

· Generates customized documents according to country specific requirements

· Delivers all documentation within agreed timelines with corresponding internal client

· Prepares lot specific Certificates of Analysis for international shipping purposes

TACTICAL:

· Performs formulation calculations to generate customized documentation

· Tracks progress and updates client when necessary

· Contacts vendors to obtain required RMCOFAS & RM data

· Coordinates special Lab testing and reporting with Nutra's QC labs and retains coordinates capture, packing, labeling and invoicing of GNC's RM samples for clients

· Retrieves and complies lab data using Lab works

· Knowledgeable and compliant with all GNC/Nutra company policies and SOP/Wls

· Maintain document compliance with FDA and foreign SOPs/Regulations/Guidelines

· Be acquainted with and adhere to country specific regulations governing document preparation

· Provides additional assistance to International Regulatory Affairs and Customer Service agents by obtaining labels, technical information and other manufacturing documents

· Provide administrative support for International Team members including courier shipments, batch records retrieval and telephone coverage

MINIMUM:

• >2 years’ experience as administrative assistant within a pharmaceutical/nutraceuticals/food/science

related or similar organization; OR two-year health or science degree may be substituted for minimum experience requirements

PREFERRED:

• >2 years’ experience as regulatory affairs assistant with a pharmaceutical or nutraceutical company

MINIMUM EDUCATION:

High School Diploma or Equivalent

Two year degree in technical degree in a related field (e.gr. chemistry, biology, food science or technology)

Qualifications:

· Savvy with strong Microsoft Outlook and Office skills, especially MS Excel Knowledgeable of administrative and clerical procedures and systems such as managing files and records, designing forms and other office duties

· Must be able to prioritize workload and timelines and following up on things

· Detail oriented and organizational skills

· Excellent verbal and communication skills, problem solving, team building and interpersonal skills

· Highly analytical and able to evaluate, analyze, and summarize large volumes of data and technical material efficiently such as lab reports, specifications and operational records

· Must be knowledgeable in cGMP requirements and familiar with the concept of Quality programs

· Must be able to type with speed and accuracy and have excellent mathematical and writing skills

· Must be able to interpret and calculate ratios and percentages, handle scientific notation and units

· Must be a self-directed individual who works under minimal supervision

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job.

Lifting up to 30 lbs might be required - Lifting (above the shoulder) sample trays and plastic crates containing product which can weigh up to 15 lbs, or lifting (chest high) sample totes and boxes weighing up to 30 lb Ability to stand for duration of laboratory bench or manufacturing work station tasks; Climb a 10' stationary ladder to read charts and store product Heavy walking at times Company provided safety shoes, lab coats, and hair nets are necessary when working within the production environment; PPE required whenever needed

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate. Offices are located in the Greenville and Anderson plants, and travel between locations is required. Some work is performed in a laboratory environment (maintained at 25 C and about 60% RH), and on the general plant floor. The work area on the 2nd floor is not accessible by elevator and requires the use of stairs. Office, manufacturing and laboratory environments

Upstate Staffing, Inc

At Upstate Staffing, our work is our passion. Because we are fully invested in the success of our clients, we are dedicated to providing the utmost in dependable customer service. We love putting people to work and that is what compels us to provide an outstanding experience for our clients every day.

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Anderson, SC
USA

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