Employer Reference: REF590D
Company 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 Senior Scientist II – Regulatory and Scientific Affairs located in Greensboro, NC.
Job Description
Job Summary:
Under general supervision, supports and is responsible for assessing regulatory impact of critical interfaces between Regulatory and Scientific Affairs (RSA) and internal and external stakeholders. Provides current knowledge and discovers new applications of company-wide importance in areas of scientific expertise. Supports and ensures successful implementation and oversight of overall corporate regulatory initiatives.
WHAT YOU WILL DO
Duties and Responsibilities:
(This list is not exhaustive and may be supplemented as necessary by the Company)
- Responsible for the Quality Control of all regulatory submissions and developing the timelines and processes for the submissions.
- Provide oversight and accountability for the primary regulatory ingredient reporting and other scientific data required for regulatory reporting through the proactive identification of the Company needs and priorities, and the utilization of computer databases and other relevant methodologies.
- Responsible for authoring, organizing, and updating the scientific and technical portions of Food and Drug Administration (FDA) Premarket Tobacco Applications such as Substantial Equivalence and Exemption Requests, Modified Risk Tobacco Product Applications, and responses to FDA requests for information.
- Enhance the effectiveness of teams and the section by maintaining good working relationships with internal and external personnel and providing supervision, assistance, and training to Departmental personnel.
- Provide support to the Manager, Regulatory Science and Director, Regulatory and Scientific Affairs and is responsible for assessing and managing the regulatory impact of critical interfaces between RSA and internal and external stakeholders, the Change Control Regulatory Risk Assessments processes and Third-Party Regulatory Engagement processes and management.
- Supports regulatory processes surrounding the regulatory submissions and approvals with any entity outside of RSA, including Imperial Group function (Product Science) or legal or regulatory consultants to review the regulatory products.
- Ensuring providers of scientific data or narratives on behalf of the Company are provided the right requirements to meet standards and understanding the project management timelines to ensure the Company has the quality and time to approve any submissions in a rigorous manner.
- Responsible for the data collection, review and submissions of reports and other relevant information to the proper authoritative areas and prepares relevant submissions to regulatory agencies by maintaining and utilizing the full ingredients database for the completion, drafting for approval and conveyance based upon the correct schedule and in the technically correct details specified by the external requirements.
Qualifications
Required Minimum Qualifications:
Education and Experience:
- Master’s Degree in Science, Engineering, or related field of study and 7+ years related work experience, OR
- Bachelor’s Degree in Science, Engineering, or related field of study and 9+ years related work experience
- Experience is to include, but is not limited to:
- Expressing advanced technical concepts from the chemical sciences to non-scientists
- Operating specific equipment to specific instrumentation
*A combination of education and experience may be accepted in lieu of degree.
Knowledge of:
- Intermediate to Advanced proficiency with Microsoft Office (Outlook, Word, Excel, & PowerPoint) and Microsoft Teams
Skilled in:
- Verbal and written communication
- Attention to detail
- Problem/situation analysis
- Effective time and task management
- Multitasking capabilities
- Flexibility and adaptability
Ability to:
- Communicate to a broad and diverse audience
- Express advanced technical concepts from the chemical sciences to non-scientists
- 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
- Travel domestically up to 5% of the time
Preferred Qualifications:
Education and Experience:
- PhD in Science or Engineering; Engineering degree in Biomedical, Environmental, or Chemical discipline preferred.
- 7+ years related work experience to include but not limited to, demonstrated experience with publication and patent records as well as project and/or program management.
Additional Information
Work Environment and Physical Demand:
- Requires moderate physical effort. Occasionally lifts or moves objects (less than 10 lbs.)
- Reach and grasp objects / hand-eye coordination.
- Walks, sits, or stands for extended periods.
- Requires prolonged machine operation including vehicle, computer, and keyboard equipment.
- Use of manual dexterity and fine motor skills.
- Experience exposure to uncomfortable work environment due to extreme temperature, noise level, or other conditions including second-hand smoke and/or vape
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
- 15 Company-paid holidays
- Generous paid time off
- Casual dress policy Monday through Friday
- Education assistance
- Employee recognition programs
- Employee referral bonus program
- Employee discounts
- Summer hours
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.
ITG Brands will follow applicable federal and state rules relating to COVID-19 vaccinations. Accordingly, applicants who receive conditional job offers should be prepared to provide information and documentation regarding vaccination status upon request by ITG Brands.
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.