Technical Documents Coordinator - International Regulatory Affairs Job
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Job Tile: Technical Documents Coordinator, International Regulatory Affairs
Job Number: 2017-51294
Date Posted: 7-24-2017
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Under limited supervision, responsible for assisting in regulatory evaluation of new product formulas, developing and compiling documentation for CTDs, processing and distribution of information and materials for product registration in target markets
Essential Duties and Responsibilities:
Essential Duties and Responsibilities
- Assist in the development and preparation of appropriate technical documentation for CTDs, work cross-functionally with manufacturing, QC and ingredient suppliers to complete CTDs in a suitable timeframe.
- Assist in procuring, preparing technical documents and working with departments within and outside GNC including the USDA, Department of State, etc, to collect relevant information to assemble materials needed for international product registrations. Review documentation and advise if changes are necessary. Communicate with franchisees to address any issues pertaining to product registration.
- Assist in the researching, action or otherwise supporting the franchisee’s requests for specialized materials (i.e. certificates etc.) which originate outside of GNC. Interact with various companies, departments and associates to obtain information and materials needed by franchisees.
- Keep abreast of relevant changes/ proposed changes to worldwide regulatory requirements. Assess impact of any new technical requirements and possibility of meeting the requirements.
- Collaborate with manufacturing and other stakeholders to facilitate processing of master change records, master batch records and deviations.
- Follow up with franchisees to ensure monthly registration reports are transmitted to GNC.
- Conducts reviews and analysis for reports as needed
- Other duties as needed
- 1-2+ years of relevant experience with CTDs in a pharmaceutical or nutraceutical company and other technical documents. Experience with regulations around manufacture of dietary supplements is desirable.
- Strong technical skills to understand and work through CTDs and other documents.
- Understanding of manufacturing and production process of dietary supplements.
- Ability to interact with franchisees in order to obtain registration updates.
- Ability to understand product registration documentation.
- Ability to work quickly under pressure with great attention to detail.
- Excellent computer skills required to generate correspondence and analysis and prepare reports.
- 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 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 include close vision. Employee is required to put on Personal Protective Equipment (i.e., lab coat, booties and hair covers, etc.) when accessing the laboratories and plant facility.
- Use of stair is required as office area is located on 2nd floor with no access to elevators.
- Position will be based in Anderson, South Carolina.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This job description reflects management’s assignment of essential job functions, which are not intended to be an exhaustive list of all responsibilities, duties and skills required.
GNC is an Equal Opportunity/Affirmative Action/Protected Veterans/Disabled Individuals Employer.