Manager, Regulatory Science in Greensboro, NC at ITG Brands

Date Posted: 7/15/2021

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/15/2021

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, to succeed, a company must treat its people well and give them the tools they need to win. We are currently searching for a Manager, Regulatory Science at our A.W. Spears Research Center located in Greensboro, NC.

 

Job Summary:

The Manager, Regulatory Science will be responsible for managing the R&SA team responsible for Tobacco Product Applications and other regulatory submissions and the process associated with the preparation of the scientific and technical portions of various types of regulatory submissions that support tobacco product pre-market clearances and approvals.

             

WHAT YOU WILL DO

Duties and Responsibilities:

(This list is not exhaustive and may be supplemented as necessary by ITG Brands)

 

  • Responsible for authoring, organizing and updating the scientific and technical portions of FDA Premarket Tobacco Applications such as Substantial Equivalence and Exemption Requests, Modified Risk Tobacco Product Applications, and responses to FDA requests for information
  • Maintaining regulatory awareness and establishing a process for ensuring that R&SA management is kept well-informed regarding the progress of existing submissions.
  • Leading the analysis of large and complex data sets to extract pertinent information and relationships for reporting to regulatory agencies and collaborates with various internal groups and external consultants to ensure that all written and oral regulatory submissions and responses to FDA requests for information are properly organized, appropriate and scientifically accurate, and completed in a timely manner.
  • Manage/lead the work of one or more professionals and enhancing the effectiveness of teams and the department by maintaining good working relationships with internal and external personnel and providing supervision, assistance, and training to Departmental personnel.
  • Promoting sustainable technical expertise by mentoring and developing select staff.
  • Identifying innovative areas of improvement and independently proposing and implementing solutions; working in a cooperative manner with the rest of the Regulatory & Scientific Affairs team and analyzing regulatory proposals/requirements, to ensure proper functioning of the program.
  • Assessing whether existing FDA-compliant change control protocols, tests or procedures are adequate to support minor product modifications or demonstrations of product equivalency to predicate products and recommending scientific approaches and strategies for addressing and eliminating data gaps.
  • Develops options for improving the current process for maintaining and updating the technical and scientific data required by FDA and other regulatory bodies under different submission pathways.
  • Develop and present solutions to business problems independently and implementing process improvements and procedures directed at measurably improving quality, capability and efficiency of the team and its deliverables to address business needs and to meet regulatory requirements.
  • Demonstrate creativity and initiative via leadership, including performing highly specialized, complex scientific assessments and analyses.
  • Critically reviewing and analyzing technical data related to product chemistry, design, and manufacturing to determine whether such information is technically accurate and adequate for regulatory submission purposes.
  • Performs other job-related duties as assigned

 

Job Requirements

Required Minimum Qualifications:

Education and Experience:

  • Doctorate degree in related field with 3+ years relevant experience OR
  • Master's degree in related field with 5+ years relevant experience OR
  • Bachelor’s degree in related field with 9+ years relevant experience

Related Work Experience, to include but is not limited to:

  • Experience in preparing FDA premarket submissions or product registration dossiers
  • Effective managerial/leadership abilities,  interpersonal skills, influencing, and problem solving skills
  • Experience with FDA CTP and matters associated with tobacco product chemistry

 

 

Knowledge of:

  • Intermediate to Advanced proficiency with Microsoft Office (Outlook, Word, Excel, & PowerPoint) and Microsoft Teams
  • Strong knowledge of regulatory, laboratory, analytical chemistry and basic analysis therory, various instrument platforms and relevant mathematical and statistical concepts and approaches

 

Skilled in:                

  • Verbal and written communication
  • Attention to detail
  • Problem/situation analysis
  • Effective time and task management
  • Multitasking capabilities
  • Flexibility and adaptability
  • Strong analytical skill set including knowledge of a variety of scientific and technically based techniques with the capability to review, understand, utilize and present complex information, including ability to cross-check and validate information

 

Ability to:

  • Communicate to a broad and diverse audience
  • Plan, organize, prioritize, and manage projects or programs
  • Maintain effective working relationships
  • Demonstrate critical thinking
  • Work with diverse populations and varying education levels
  • Receive and communicate information orally and in writing
  • Prioritize assignments, workload, and manage time accordingly
  • Ability to thoroughly complete data analyses, communicate findings to Senior and Executive Management, and be able to field questions or inquiries while considering the conclusions and limitations of data analyses
  • Ability to travel internationally & domestically up to 15%

 

Preferred Qualifications:

Experience:

  • Preparing and submitting FDA CMC DMF, 510K, PMA, IND or NDA submissions

Work Environment and Physical Demand:

 

  • Requires light physical effort. Occasionally lifts or moves light objects (under 10 lbs.).
  • Walks, sits, or stands for prolonged periods.
  • Requires prolonged machine operation including computer and keyboard equipment.

 

This job description is intended to be generic in nature and describe the essential functions of the job.  It is not necessarily an exhaustive list of all duties and responsibilities.  The essential duties, functions and responsibilities, and overtime eligibility may vary based on the specific tasks assigned to the position.

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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