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
- 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:
Education and Experience:
- Advanced degree in Life Sciences, Chemistry, Regulatory Affairs, Business, or related discipline with 10+ years related work experience.
Knowledge of:
- 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
• Casual dress policy Monday through Friday
Annual Base Salary Range: $119325.00 - $159100.00
Final compensation will be determined based on experience, qualifications, and internal equity. This role may also be eligible for annual bonus or incentive compensation.
Applicant InformationThis job description describes the essential functions of the job at the time the job description was created, but it is not an exhaustive list of tasks, duties and responsibilities. In addition, the position may evolve or change over time and such changes may not be reflected in the job description until it is next updated.
