Director, Regulatory Affairs

SCN BestCo•Mooresville, NC

About The Position

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.

Requirements

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.
Strong knowledge of drug cGMP and FDA requirements.
Strong leadership, financial acumen, problem-solving, organizational development, attention to detail, judgment, and legal research skills.
Ability to lead with a high commitment to team values.
Proven business acumen, innovation, strategic thinking, professionalism, and visionary leadership skills.
Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Outlook.
Ability to apply complex mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to tasks such as frequency distribution, determining test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to routine inquiries or complaints from clients, regulatory bodies, or business community members.
Ability to write speeches and articles for publication according to prescribed style and format.
Ability to effectively present information to senior executives, management, public groups, and/or boards of directors.
Must demonstrate practical problem-solving and troubleshooting skills.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and handle multiple abstract and concrete variables.

Nice To Haves

Advanced degree in scientific or business administration.
Quality assurance, quality control, regulatory compliance, and/or pharmaceutical manufacturing experience.
Bilingual in English/French.

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 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.
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.