The Director/Senior Director, Commercial Regulatory Affairs will guide, direct and coordinate the strategic planning and execution of the regulatory solutions to diverse promotional scenarios in support of the launch of ZS Pharma’s lead compound. In this role, you will ensure that advertising, labeling and promotional materials meet regulatory and company standards.
• Creates, develops, implements, organizes and provides regulatory insight for all ZS Pharma review committees(Promotional & Medical Review)
• Develops collaborative relationships with internal stakeholders, external regulatory agencies and experts
• Reviews promotional and medical affairs materials and provides alternative solutions, when appropriate
• Builds a strong and credible relationship with health authorities related to promotional labeling, product labeling and advertising
• Represents ZS Pharma at internal programs, project meetings, committees and during internal audits of promotional activities
• Ensures globally harmonized approach for labeling creation and implementation through the company design control process
• Forms strategic partnerships with the Business Commercial, Medical Affairs, and Pharmacovigilance leadership
• Supports the development, submission, and maintenance of product labeling and promotion to regulatory agencies
• Reviews and updates SOPs
• Maintains up-to-date knowledge of laws, regulations and policies enforced by the regulatory authorities as they relate to product labeling, promotional materials and advertising
• Provides regulatory expertise, in a matrix environment, to ensure business and regulatory needs are met
• B.S. mandatory. Advanced degree in scientific discipline desirable.
• Minimum 5+ years in pharmaceutical industry with increasing levels of expertise/experience
• Experience in a regulatory function in the area of labeling and advertising promotion is a must
• Experienced in a start-up, fast paced, flexible and dynamic environment is critical
• A roll-up your sleeves style is essential
• Established understanding of product registration processes and their interdependence with product and promotional labeling
• Strong, proactive, strategic thinking and leadership skills
• Excellent communications skills (verbal and written)
• Proven negotiation, facilitation and influencing skills
• Teamwork, problem-solving ability, customer/patient focus and quality orientation
ZS Pharma, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact firstname.lastname@example.org.