The Regulatory Affairs Director leads a regulatory team and is responsible for ensuring the company is at the forefront of industry regulatory understanding. This position creates and drives regulatory strategy and ensures regulatory compliance. The Regulatory Affairs Director oversees the regulatory aspects of new product innovation, existing product changes or updates, and assures products and services are planned and implemented in a manner compliant with FDA, third party endorsements, and other applicable regulatory requirements. As a member of the leadership team, the Regulatory Affairs Director closely partners with Quality, collaborates with cross functional teams, site leadership, and members of the Senior Leadership Team to ensure successful attainment of all business goals and objectives.
Essential Duties and Responsibilities- Partner with cross functional partners to drive more efficient and robust processes whilst maintaining the agility needed to succeed (e.g., claims support, raw materials qualification, etc.).
- Oversee regulatory compliance assessments of new and revised product labeling as well as any related communication with health and regulatory authorities.
- Drive and maintain structure function claim documentation and improve internal tools and databases to support product labeling claims.
- Identify legal risks regarding product labels, provide risk management and mitigation plans, and communicate this information to sales and marketing, as well as senior leadership, as needed.
- Provide regulatory input and feasibility assessments for new product development efforts by proactively gathering relevant information and/or justification.
- Create regulatory systems and processes. Implement and maintain a robust document management system.
- Oversee the development, improvement, and maintenance of Standard Operating Procedures (SOPs) related to the Regulatory functional area. As needed, review and contribute to cross functional SOPs.
- Establish and maintain regulatory archives in compliance with applicable regulatory requirements.
- Collaborate with other departments and senior management to develop sound quality agreements, product dossiers, and label agreements.
- Oversee all filings to regulatory authorities (e.g., site licensing for Health Canada, biannual FDA registration, etc.).
- Maintain knowledge of current applicable regulatory requirements including 505c and translate these requirements into Company policies and procedures.
- Maintain knowledge of current applicable regulatory requirements including current Good Manufacturing Practice (cGMP), 21CFR:210, 211 and translate these requirements into Company policies and procedures.
- Maintain professional and technical knowledge by attending education workshops and reviewing professional publications.
- Provide insight and guidance on emerging regulatory opportunities and challenges.
People Leader ResponsibilitiesThe position carries out People Leader Responsibilities in accordance with the Company's policies and applicable laws. Responsibilities include:
- Direct or indirect supervision of staff to include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding, and administering corrective actions; and addressing complaints and resolving problems.
- Manage, mentor, and coach direct reports including hiring, performance management, and professional development. Ensure continuous development of the Regulatory team.
- Ensure the safety and quality standards expected of all SCN BestCo staff are met.
Required QualificationsEducation & Experience:- Bachelor's degree in law, business administration, food science or related field.
- 12 years' professional experience in regulatory compliance and/or quality assurance.
- 10 years' progressive supervisory/management experience.
- 3 years' OTC and/or pharmaceutical industry experience including FDA and Health Canada policies and procedures.
Knowledge, Skills, & Abilities (KSAs):- Strong knowledge of drug cGMP and FDA requirements.
- Strong leadership, communication, problem-solving, organizational development, analytical & presentation skills.
- Financial acumen, oral and written communication skills.
- Ability to lead with a high commitment to team values.
- Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Outlook.
- Proven business acumen, innovation, strategic thinking, professionalism, visionary leadership, and problem-solving skills.
- Strong attention to detail, judgment, legal research, written communication, and organizational skills.
Preferred Qualifications- Advanced degree in scientific or business administration.
- Quality assurance, quality control, regulatory compliance, and/or pharmaceutical manufacturing experience.
- Bilingual in English/French.
