Director of Regulatory Affairs
VP, Quality Assurance and Regulatory Affairs
As the Director of Regulatory Affairs, you are responsible for the overall regulatory compliance, licensing, reporting, and planning for the laboratories, including both hemp and marijuana. Even though you have the option to delegate some of your responsibilities, you remain ultimately responsible and must ensure that all the duties are properly executed, and applicable regulations are met. It is your responsibility to ensure that your laboratory develops and uses an appropriate quality system approach to laboratory testing that provides accurate and reliable test results.
Major Duties and Responsibilities:
- Provides leadership in regulatory activities to promote a complete state of compliance in incumbent and future testing operations.
- Responsible for licensing and regulatory compliance to CDPHE, MED, ISO, AOAC, as well as 50 state compliance. Additional regulatory bodies not listed may be applicable.
- Monitors state and federal level developments regarding hemp and marijuana regulations
- Informs Executive Leadership of issues, concerns, or problems that might lead to regulatory non-compliance before they happen.
- Liaises with regulatory officials and is responsible for submissions to and any ongoing communication with regulatory bodies
- Works with legal counsel to ensure any ambiguous regulations are assessed for risk.
- Assists in budget development for the department.
- Manages expenses to budget.
- Develops, monitors, and makes continuous improvements in the regulatory department based on KPIs and other metrics.
- Implements Continuous Quality Improvements to processes and measures effectiveness.
- Participates in regulatory and partner audits as required.
- Ensures team adherence to approved SOPs.
- Hires, integrates, and develops high quality talent, capable of delivering against the department goals and objectives.
- Develops our next generation of leaders through mentorship, training, coaching, and feedback.
- Works with R&D to efficiently transfer method changes, updates, and developments into laboratory practice.
Knowledge and Skill:
- A minimum of 10 years experience in senior leadership roles within regulated industries. Cannabis experience is a plus.
- Demonstrated experience successfully managing ISO 17025 accredited entities.
- Sufficient knowledge of all testing provided and compliance to the regulations.
- Experienced in KPI development and management.
- Experience in building and growing an organization into a high-performance team.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills are required.
- Previous work responsibility, which required a high degree of attention to detail.
- Well-practiced in exercising sound judgment in decision-making.
- Demonstrated prioritization and organization skills.
Work is performed in a mixed laboratory office environment and requires extensive computer, employee involvement, and customer interface work. Laboratory work requires the use of PPE as appropriate. Travel between laboratories to manage staff and regulatory compliance.
Take action, final decision, recommend.
Exercises judgment within generally defined practices and policies in driving toward solutions. Acts as an advisor to staff to resolve problems. Develops performance requirements and evaluates staff members accordingly. Establishes and recommends changes to policies which affect subordinate organization. Erroneous decisions will result in critical delays in schedule and or unit operations and may jeopardize overall business activities.
The Director of Regulatory Affairs acts independently in all the Duties and Responsibilities listed. Receives guidance in the form of objectives and establishes goals to meet objectives from Executive Leadership. Provides guidance to staff to achieve goals in accordance with established policies. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
Required to provide guidance, oversee the activities, and participate in the on-the-job training of less experienced staff. Potential direct supervision of as many as 3-4 employees and 1-2 indirect staff.
- Obtain an Occupational License from the Colorado Marijuana Enforcement Division
$125,000 – $165,000 per year
- Medical/Dental/Vision Insurance
- 2 weeks paid time off
- 7 paid holidays
Must be 21 years or older
Apply for this Position
Botanacor Laboratories is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.