Senior Director, Regulatory Advertising, Promotion And Labeling

Senior Director, Regulatory Advertising, Promotion and Labeling  

The Company:

Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this through the development of our first-in-class molecule, ensifentrine. Ensifentrine has the potential to provide relief for millions of patients suffering from a variety of respiratory conditions including chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and asthma. Our focus is driven by our desire to ensure that innovative and differentiated molecules can reach these patients.

The experience of the Verona team, and its highly effective leadership allows us to challenge the status quo in drug development and commercialization. Verona provides a professional, diverse, and inclusive working environment where our employees thrive. We are driven to succeed by our desire to help those dealing with the chronic progressive nature of respiratory diseases. We offer you the opportunity to help create a new future for those people living with respiratory diseases.

The Opportunity:

Verona Pharma is currently recruiting a Senior Director, Regulatory Advertising, Promotion and Labeling to join our team in Raleigh, North Carolina, reporting to the Senior VP, Regulatory Affairs. Remote working and flexibility are important parts of our culture at Verona. However, we are looking for candidates based in the Raleigh/Durham/Chapel Hill area as you will periodically be required to go into the Raleigh office for key meetings, training, and other activities as needed.

In the role of Senior Director, you will be responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner and in accordance with business goals and objectives, FDA regulations and guidance, and company policies.

To be successful in this role, you will collaborate with Medical, Legal, Commercial, and Compliance to execute and approve key commercial campaigns as well as take on a senior leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target, and product labeling.

Responsibilities:

• Review/approve promotional, medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies/best practices.
• Collaborate with Medical, Legal, Commercial, and Compliance to execute and approve key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk.
• Develop and maintain labeling documents (e.g., prescribing information) for Verona products.
• Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
• Assumes a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target, or product labeling, and to provide strategic regulatory guidance on corporate communications and appropriate pre-approval and/or disease education communications.
• Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.

Requirements:

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• You have a minimum of 10 years of experience in drug, biologic and/or combination products in Regulatory Affairs or related field.
• Minimum of 10 years of experience in Regulatory Affairs promotion and advertising working with prescription drug, biologic, and/or combination products; experience managing regulatory filing(s) to the FDA Office of Prescription Drug Promotion. 
• Understand the processes and techniques used within a clinical development environment, can contribute to clinical study design discussions.
• Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion and product labelling. Knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders.
• Experience writing and implementing company procedures pertaining to advertising and promotional review and labelling.
• Extensive experience in managing complex negotiations with internal as well as external stakeholders.
• Demonstrated leadership skills. Ability to manage and bring working teams together for common objectives.
• Excellent oral and written skills.
• Ability to work across projects simultaneously with impeccable time management skills.
   

Why Join Us?

We know our employees are our most valuable asset, and our culture conveys that. Trust, Accountability and Efficiency are core values that drive our working environment.  All employees work from home, and we welcome employees who wish to come into our Raleigh office, when they wish to come in.  All employees are issued laptops and a new hire stipend of $650 to purchase any needed equipment to set up an efficient and effective home office.  Our employees use their personal cell phones for work, and they receive a $100 stipend each month to help cover those costs.  We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

An Equal Opportunity Employer

Verona Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Verona Pharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

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