What are the responsibilities and job description for the Regulatory Affairs Director position at Duke Cannon Supply Co.?
Regulatory Affairs Director
Duke Cannon Supply Co. is a growth-oriented CPG company that operates with an entrepreneurial mindset – and has become one of the fastest-growing brands in the men’s grooming category. Our mission is to better the day of hard-working men, and we fulfill this mission through the products we build, the conversations we create, and our give-back program to veterans.
We are currently seeking applicants for the role of Director, Regulatory Affairs. This position will be responsible for regulatory oversight and management across the entire portfolio of products. This role requires a deep understanding of regulatory requirements across multiple product types and knowledge and experience with existing and emerging state and federal regulations.
PRIMARY RESPONSIBILITIES:
- Maintain up-to-date knowledge of regulations for OTC drug and cosmetic personal care products including 21 CFR Parts 11, 701, 210, and 211, applicable OTC Monographs, MoCRA, ISO 22716, and relevant ICH quality guidelines (Q7, Q9, Q10).
- Remain current on new regulatory policies and processes to advance compliance strategies and foster a strong regulatory culture.
- Lead process for product and reporting compliance with U.S. federal and state laws (e.g., FDA product listings, CA Prop 65, CSCP, EPR, etc.).
- Complete safety substantiations for cosmetic and OTC drug products, ensuring appropriate documentation and scientific justification to support product safety.
- Collaborate with Product Development to integrate safety and quality considerations into product design, ensuring compliance with regulatory requirements and supporting a Quality and Safety by Design approach throughout the development lifecycle.
- Lead process with suppliers to request, obtain, and critically review regulatory documentation for components, raw materials, and finished products to verify compliance with applicable regulations and confirm alignment with brand standards.
- Approve labeling, marketing, and promotional materials for OTC drug and cosmetic products to ensure accuracy and regulatory compliance.
- Manage WERCS registrations and ensure compliance with all retail partner requirements to support product acceptance, regulatory reporting, and ongoing market access.
- Assess for and communicate regulatory risks to management and cross functional teams
- Provide regulatory support and guidance during inspections and audits.
- Manage Safety Data Sheets (SDS) and maintain SOPs related to regulatory affairs, ensuring document control, version compliance, and completion of required employee training.
- Bachelor's Degree (B.S.) in an appropriate scientific field of study required (preferred fields of study include Microbiology, Biology, Chemistry, or Biochemistry).
- 10 years of regulatory experience in Personal Care, OTC or related fields
- In-depth Knowledge and experience on FDA regulatory requirements, as well as of cGMP standards (21 CFR Parts 11, 701, 210, and 211, MoCRA, ISO 22716, ICH Q7, Q9, Q10).
- The ideal candidate will have experience building and implementing a quality management system and department while nurturing a strong cultural commitment to quality.
- Demonstrated continuous improvement mindset with strong attention to detail and high level of operational organization
- Ability to communicate clearly and work effectively with internal and external business partners
- Self-starter with a strong sense of follow up and ability to prioritize competing priorities
Duke Cannon Supply Co. offers a fast-paced environment where decisions are vetted quickly, and opportunities are relentlessly pursued. We work hard, but we value flexibility as well. We have an informal culture with an emphasis on having fun (we sell soap, after all), though we have the most fun when we exceed our goals. The company’s leaders are dedicated to the growth and development of the team; as such, we want to ensure that our people have a rich and rewarding experience with unique opportunities to grow.
Duke Cannon Supply Co.’s Main Lodge (aka the office) is in Minneapolis’ North Loop, one of the city’s most vibrant and walkable neighborhoods, with award-winning restaurants, fashionable boutiques, live music and Major League Baseball just steps away.
SALARY AND BENEFITS
Duke Cannon offers a competitive market salary and bonus based on role and professional experience. The salary range for this position is $140,000 - $170,000. Our benefits are top-notch and include health & dental insurance, HSA and 401k programs supported by regular company contributions, a tuition reimbursement program, and monthly parking stipend. We also host monthly moments of Team camaraderie ranging from community service events to social hours in the Main Lodge (aka the office) to Lunch & Learns covering business, team, and industry topics.
Duke Cannon provides equal access to and opportunity in employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression.
Salary : $140,000 - $170,000