Regulatory Affairs Analyst I in Greensboro, NC at ITG Brands

Date Posted: 9/16/2020

Job Snapshot

Job Description

If working for a company that values its people and recognizes the importance of work/life balance is appealing to you, look no further than ITG Brands!

WHO WE ARE


ITG Brands is the U.S. division of Imperial Brands. We are the nation's third-largest tobacco company with offerings of some of the most well-known cigarette, cigar and vaping products. ITG Brands carries at its core, the mindset that, in order to succeed, a company must treat its people well and give them the tools they need to win.  We are currently searching for a Regulatory Affairs Analyst I for our A.W. Spears Research Laboratory located in Greensboro, NC.

 

As the Regulatory Affairs Analyst I, you will support corporate  FDA regulatory reporting requirements for tobacco products by coordinating information collection among various departments, providing research, analyzing thoroughness of information submitted in regulatory filings, maintaining and meeting the schedule of regulatory submission deadlines, engaging with regulators as appropriate and ensuring compliant filings for existing products as well as new products with pre-market and post-market information. Interact with regulatory agencies to ensure proper documentation and processes to provide compliant regulatory filings according to specific filing deadlines.  Supports the Senior Director, Product Integrity and Compliance Team in assigned projects related to the design, implementation, and oversight of the implementation and oversight of the corporate regulatory compliance initiatives.

 

WHAT YOU WILL DO

 

  • Supports the department in interactions with other departments and FDA and other regulatory bodies by fulfilling all relevant regulatory bodies' requirements through the provision of documentation to ensure the tobacco product business meets statutory requirements for operation in a regulated industry.  
  • Determines required information and resource deployment needs, manages the document and information collection process, and collaborates with department heads to ensure complete regulatory filings.
  • Drives, supports and reviews the collection and compilation of data and documents for tobacco products, and presents finished work product for approval to Manager, including all documents and operational data required for compliance with regulatory submissions for pre-market registrations and filings within areas of responsibility; and, supports the projects required to ensure submission to relevant department heads all post-market reports responding to questions or providing additional information to regulators as needed. 
  • Provides substantive input in the development of the corporate Regulatory & Scientific Affairs policies, communication plan, process information, and corporate Standard Operating
  • Procedure (SOP) documents; and oversees the process resulting in training materials through engagement with internal and outside parties (outside counsel); assists with the delivery of relevant Compliance training for all product lines, occasionally taking the role of the lead trainer; oversees the compilation of the documents to be used in training to further the development and efficient operation of the Compliance organization.
  • Interact internally with professional staff in Product Integrity and Compliance, Operations, Marketing, and the Legal departments to obtain relevant information about new products, revised regulatory requirements, and filing documentation, which the incumbent is accountable for.
  • Manages assigned projects independently, performs, monitors, and reports on such assigned projects by engaging with relevant departments, coordinating the compilation of relevant documents and information in support of regulatory filings, and reports submitted to senior management. Interacts internally with professional staff in QProduct Integrity and Compliance, Operations, Marketing, and the Legal departments to obtain relevant information related to new products, revised regulatory requirements, and filing documentation, which the incumbent is accountable for.
  • Supports the development of the regulatory compliance database and regulatory communications and maintains the data and approval with scheduled updates to ensure accurate and current regulatory compliance information.
  • Maintains current knowledge of tobacco product regulations, including proposed and final rules relevant to the tobacco industry position and regulatory trends as they become public. 
  • Researches press releases and pertinent news articles involving FDA or other regulatory bodies that may impact the tobacco industry.
  • Prepares the schedule of required regulatory reporting of various monthly, quarterly and annual reports for submissions to agencies, manages the internal information and resources collection process on behalf of Regulatory & Scientific Affairs, responds to agencies' questions regarding product information or issues as needed, and ensures schedules and interpretations of required submission data meet current regulatory requirements.
  • Provides advisory input in departmental operational budget and input into the R&SA budget as it pertains to state certification according to historical knowledge of departmental needs.

 

 

Job Requirements

JOB REQUIREMENTS

  • BS/BA degree in a related field of study with 5 years of related experience.  
  • Organized, analytical, and detail-oriented.  
  • Keen sensitivity for confidential information.  
  • Achievement-oriented to meet regulatory deadlines.  
  • Proficiency in word processing, spreadsheets, database maintenance, and presentation software. Competent oral and written communication skills.  
  • Effective interpersonal skills.
  • Paralegal certification is preferred. 

 

 

 

 

 

PERKS OF WORKING AT ITG BRANDS

  • Competitive benefits package that includes medical/dental/vision/life insurance/disability plans
  • Dollar for dollar 401k match up to 6% and 5% annual company contribution
  • 14 Company-paid holidays
  • Generous paid time off
  • Casual dress policy Monday through Friday
  • Education assistance
  • Employee referral bonus program
  • Employee recognition programs
  • Employee discounts, including Verizon Wireless and select car manufacturers

COMPENSATION

  • The salary range for this position is $48,000 - $65,000

TO APPLY

If you are a qualified candidate and interested in this position, we encourage you to visit our website at www.itgbrands.com

All candidates must consent to an independent investigation of their background, references, past employment, education, criminal record, and drug screening.

ITG Brands provides equal employment opportunities to all employees and applicants without regard to race, color religion, sex, national origin, sexual orientation, disability, gender identity, protected veteran status, or other protected class.

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