Regulatory Science Project Manager -(US)

ITG Brands; North Carolina; Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid workplace - remote/in office

Education assistance

Employee recognition program

401k with company match

Job summary

ITG Brands is seeking a Regulatory Affairs Senior Manager to lead regulatory strategy and compliance initiatives across the product lifecycle. You will coordinate cross-functional teams, prepare regulatory submissions, and provide expert guidance on regulatory and scientific matters affecting the portfolio.

The role requires 5+ years in Scientific Project Management, a life sciences background, and strong communication skills.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Regulatory Affairs, Business, or related discipline with 5+ years of Scientific Project Management experience.
• Advanced degree in Life Sciences, Chemistry, Regulatory Affairs, or related discipline is preferred with 10+ years related work experience.
• Demonstrated knowledge of SAP, budgeting, and project management software.

Responsibilities

• Lead regulatory strategy and compliance initiatives across product development lifecycles.
• Coordinate cross-functional teams (Legal, R&D, Supply Chain, Marketing, Finance).
• Prepare and submit regulatory documentation to governing agencies.
• Provide expert guidance on regulatory and scientific matters affecting the product portfolio.
• Develop and track project plans, milestones, budgets, and risks.

Skills

Verbal communication

Written communication

Attention to detail

Time management

Multitasking

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Chemistry, Regulatory Affairs, Business, or related discipline

5+ years of Scientific Project Management experience

Advanced degree (preferred) in Life Sciences, Chemistry, Regulatory Affairs, or related discipline

Tools

SAP

Budgeting

Project Management software

Job description

Who We Are

ITG Brands is the third-largest tobacco company in the USA with offerings of some of the most well-known cigarette, cigar, and e-vapor brands. As a member of the globally recognized Imperial Brands PLC family, we are a forward-thinking partner with operational integrity.

Who We Are

ITG Brands is the third-largest tobacco company in the USA with offerings of some of the most well-known cigarette, cigar, and e-vapor brands. As a member of the globally recognized Imperial Brands PLC family, we are a forward-thinking partner with operational integrity. ITG Brands is committed to putting consumers at the center of what we do, while creating an innovative workplace where inclusion, creativity, and bold thinking drive progress. This empowers us to bring our true selves to work, to collaborate more effectively through showing our passion and being confident to bring new ideas to the table. We are not afraid to seize opportunities and make things happen – both individually and collaboratively. We strive to exceed expectations by seeing things differently and doing things differently. This truly is a place where we all share a challenger mindset which drives our success.

What You Will Do

• JOB SUMMARY

Under general supervision, this role is responsible for leading and executing regulatory and scientific affairs initiatives that ensure product compliance and support business objectives. Acting as a subject-matter expert and project lead, the position drives regulatory strategy, manages complex cross-functional projects, and oversees the preparation and submission of regulatory documentation. The role bridges scientific, regulatory, and business teams to ensure timely, compliant product development and portfolio management.

• WHAT YOU WILL DO

(This list is not exhaustive and may be supplemented as necessary by the Company)

Regulatory Strategy & Compliance

• Interpret and apply regulatory requirements (FDA, federal, state, and international) to product development and lifecycle management.
• Translate evolving regulatory trends and policies into actionable business practices and compliance strategies.
• Assess regulatory risks and develop mitigation plans to ensure ongoing compliance and business continuity.
• Prepare, review, and submit regulatory documentation and scientific information to governing agencies.

Scientific & Technical Leadership

• Lead development and organization of scientific data packages supporting regulatory submissions.
• Analyze scientific, technical, and regulatory data to support product approvals and market readiness.
• Provide expert guidance to internal stakeholders on regulatory and scientific matters affecting the product portfolio.

Project & Program Management

• Manage end-to-end regulatory and compliance projects, including planning, execution, monitoring, and delivery.
• Develop project plans, timelines, milestones, and budgets; track progress and ensure deliverables are completed on time and within scope.
• Define and communicate project metrics, status updates, risks, and dependencies to stakeholders.
• Collaborate with cross-functional teams (Legal, R&D, Supply Chain, Marketing, and Finance) to ensure alignment and execution.

Stakeholder Engagement

• Serve as the primary liaison with internal stakeholders and external regulatory bodies, partners, and industry groups.
• Facilitate communication across diverse teams and ensure alignment on regulatory priorities and project execution.
• Support responses to regulatory inquiries and audits.

Process Improvement & Operational Excellence

• Identify gaps and implement improvements in regulatory processes, tools, and documentation systems.
• Enhance efficiency, quality, and compliance through continuous improvement initiatives.
• Support development of templates, standards, and best practices for regulatory and project management activities.

Qualifications

• REQUIRED MINIMUM QUALIFICATIONS:

Education and Experience:

• Bachelor's Degree in Life Sciences, Chemistry, Regulatory Affairs, Business, or related discipline with 5+ years of Scientific Project Management experience.
• Must be 21 years of age or older.

Knowledge of:

• Strong proficiency with Microsoft Office (Outlook, Word, Excel, & PowerPoint) and Microsoft Teams.
• Project management methodologies and approaches.
• Strong working knowledge of regulatory frameworks and submission processes
• Demonstrated experience managing complex, cross-functional projects from initiation through completion

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.
• Maintain effective working relationships.
• Prioritize assignments, workload, and manage time accordingly.
• Work with business partners in different time zones.
• Work a fluctuating work schedule.

PREFERRED QUALIFICATIONS:

• Advanced degree in Life Sciences, Chemistry, Regulatory Affairs, Business, or related discipline with 10+ years related work experience.

Knowledge of:

• SAP
• Budgeting
• Project Management software

Licenses / Certifications:

• Lean Six Sigma and/or PMP certification

Work Environment and Physical Demand

• Requires moderate physical effort. Occasionally lifts or moves objects up to 10 lbs.
• Walks, sits, or stands for extended periods.
• Reach and grasp objects / hand-eye coordination.
• 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, and other conditions including second-hand smoke and/or vape.

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.

What We Offer

• 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
• Employee recognition and discount programs
• Education assistance
• Employee referral bonus program
• Hybrid workplace - remote / in office
• Summer hours