Senior Director, Regulatory Affairs

2 weeks ago

Raleigh, United States Verona Pharma Full time
Job DescriptionJob DescriptionSenior Director, Regulatory Affairs

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), non-CF bronchiectasis, 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 Affairs to join our team, reporting to our Senior Vice President, Regulatory Affairs. In the role of Senior Director, Regulatory Affairs, you will be responsible for overseeing and directing regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. You will develop and implement strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.

To be successful in this role, you must be able to work individually, within a multi-disciplinary team, and with external partners and vendors.

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.  We have a unique opportunity to build a company that will bring a first-in-class medication to chronic respiratory disease patients with significant unmet needs.  We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

Responsibilities:
 
  • Lead and manage the compilation and submission of new Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs).
  • Facilitate cross-functional writing of reports, IND sections, protocols, etc.
  • Support regulatory submissions, as well as review, edit, and write documents as needed.
  • Prepare and submit INDs, IND amendments, CTAs, marketing applications, and other regulatory submissions.
  • Work closely with functional leaders of the company to produce high quality submissions.
  • Provide strategic and tactical input to project teams.
  • Assume responsibility for IND/CTA maintenance, including routine / substantial amendments, annual update reports, and annual IB updates.
  • May coordinate and lead communication with the relevant personnel at the FDA and other Regulatory Authorities.
  • Support the preparation and conduct of agency meetings as necessary, including preparation and coordination of meeting requests and briefing packages.
  • Manage contract staff and vendors as needed to support regulatory activities, including oversight.
  • Coordinate with regulatory vendors as needed to generate documents suitable for regulatory submissions.
  • Liaise with cross-functional team members to ensure consistent messaging related to development activities (e.g., ensure response to questions are consistent to EC’s /IRB’s and Regulatory Authorities.)
  • Identify regulatory risks and provide mitigation suggestions leading to informed decision-making.
  • Other duties as assigned.

Requirements:
 
  • Bachelor's degree required. Advanced degree preferred.
  • Minimum of 10 years in the pharmaceutical / biotech industry with a minimum of 7 years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry.
  • Experience preparing Health Authority packages, including meeting briefing packages, for FDA and/or EU meetings.
  • Regulatory experience with respiratory/ inhaled products preferred.
  • RAC certification from the Regulatory Affairs Professionals Society preferred.
  • Good understanding of global regulatory environment.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple tasks with autonomy.
  • Comfortable in a fast-paced environment.


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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