Regulatory Document Specialist

Regulatory Document Specialist - Garland, TX

GENERAL DESCRIPTION:    As the Regulatory Document Specialist, this role provides support for product documentation and compliance for both new and existing products.  Assists with maintaining new and renewal of applications for outside agencies, prepares foreign registration documents and ensures timely response to department projects.

ESSENTIAL DUTIES/RESPONSIBILITIES/FUNCTIONS:

• Support Regulatory Affairs Specialist by preparing technical documents for country specific needs, product registration documents, etc.
• Assist with maintaining product files, product certifications, etc and updating them in Ensur and performing yearly documentation review.
• Assist with preparing special documentation, per request, for countries that have problems releasing a shipment, if needed.
• Prepare technical documents to support a country with registration needs or consumer requests/complaints.
• Prepare special documents per request from the Regulatory Affairs Specialist that require legalization and send via Federal Express or USPS (as appropriate) to the appropriate Consulates General.
•  Assist with regulatory document submissions to IASC, IFANCA, the Halal certifying agency, and to the Rabbi for initial certifications and certification renewals.
• Request Certificates of Free Sale from the Texas Department of State Health Services.
• Order Certificates of Authentications and Apostilles from the Texas Secretary of State.
• Complete a Health Certificate, Export Certificate, Animal Products VS Form 16-4 form to order Export Certificates from the United States Department of Agriculture.
• Archive electronic e-mails and scanned documents into designated archiving drive.
• Prepare all required documents using Word, Excel and e-mail.
• Prepare all documents for foreign countries in English.
• Work efficiently to meet all deadlines and respond timely to all requests.
• Assist with maintenance of spreadsheets and tracking tools for measuring department objectives.
• Work cooperatively with co-workers and supervisors.
• Maintain regular and punctual attendance at work.
• All other duties as assigned.

QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:

• Detailed-oriented – accurate, timely work product.
• Good verbal communication skills.
• Knowledge of basic office procedures and ability to operate office equipment including copy machine, fax, telephone, and PC.
• Some knowledge of regulatory and compliance matters.
• Proficient in MS Office programs.
• Able to read, write and speak English as all documents are prepared in English.

PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES:

• Able to stand/remain upright about 2 – 3 hours at a time.
• Sit for long periods, up to 4 hours at a time.
• Use keyboard and computer.
• Sit, stand, reach forward and overhead, kneel, twist, turn and bend.
• Lift and carry boxes with product samples to waist height up to 40 lbs., when needed.

EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:

• High School Diploma or equivalent.
• Some college coursework preferred.
• At least 2 years work experience in regulatory, quality and/or compliance matters preferred.  
• Minimum 3 years work experience with MS Office applications.