Senior Director, Regulatory Affairs

This is a remote opportunity, however location in / around the state of Virginia is strongly preferred. Candidates based remotely can expect travel requirements up to 25% of the time.

Kaléo has secured multiple contracts with the U.S. government for the development and production of new medical countermeasures, with commercialization opportunities to follow. We are expanding our Regulatory leadership team to facilitate this growth.

At Kaléo, our way is not to seek to be like others, but rather to passionately pursue meaningful and innovative solutions for patients. We believe all people should have access to the innovative healthcare products and solutions that empower each of them to live fuller, bolder lives. The Senior Director, Regulatory Affairs, will play a key role in delivering these solutions successfully, and serving as the internal Regulatory Affairs subject matter expert (SME).

As Senior Director, you will have broad scope and responsibility for leading all regulatory functions. The Regulatory Affairs team plays a key role in planning and executing the development of new products from conception, performance of regulatory gap analyses, through product development (IND stage), and culminating in the submission and review of a New Drug Application. Upon approval, the team works with various stakeholders to support all post-approval regulatory obligations. On any given day, you will be working across a spectrum of regulatory issues for both drug and device regulations. This includes direct interaction with external regulatory consultants, partners such as the U.S. Department of Defense, and regulatory bodies such as the FDA.

You will be part of a close-knit, fiercely collaborative team that takes pride in being the best at what they do.

As Senior Director, Regulatory Affairs, you will be responsible for:

Department Management

• Direct all regulatory matters and lead strategy to ensure compliance with applicable regulations.
• Serve as primary liaison between regulatory bodies other key stakeholders including senior management and external partners.
• Lead and manage Regulatory Affairs team members.
• Recruit, retain and develop regulatory team members, contractors and consultants to meet organizational goals.
• Accountable for compliance with Transfer of Regulatory Obligation Agreements as applicable for work with development partners.
• Accountable for Regulatory Policies and Standard Operating Procedures to facilitate compliance with regulations.
  
  

Regulatory Strategy

• Stay abreast of new regulatory requirements and interpret existing requirements as they relate to Kaléo's products, procedures, testing, and records keeping; communicate related requirements to team members and upper management.
• Develop and implement regulatory strategies for programs in all phases of development. Conduct program meetings to assign and manage plans, roles, responsibilities, and timelines.
• Lead development of regulatory proposals for new programs.
• Lead regulatory evaluation and execution for Pediatric Research Equity Act compliance, Orphan Drug designation, regulatory exclusivity pathways (i.e., Breakthrough designation, Fast Track, Priority Review), and Emergency Use Authorization.
  
  

Regulatory Operations

• Lead interactions with personnel at regulatory agencies, partners (corporate and government), and vendors.
• Lead regulatory meeting conduct: preparation of meeting packages, meeting logistics, preparation of subject matter experts, and overall meeting leader.
• Co-host or lead Kaléo regulatory inspections.
• Accountable for preparation and timely submission of regulatory submissions including INDs, NDAs, Annual Reports, periodic safety reports, responses to information requests, and briefing documents.
• Review and approve development plans, design and manufacturing changes, nonconforming materials reports, rework orders, test protocols, and reports to ensure compliance.
• Serve as product subject matter expert for labeling, product claims, training materials, publications, press releases or marketing programs in collaboration with our compliance team.
• Advise on international product registration and export approval requirements.
• Ensure compliance with PDUFA prescription drug program fee payment.
  
  

To be considered for the position, you must have:

• Bachelor's degree in a scientific discipline.
• At least 15 years of increasingly responsible experience in the pharmaceutical, biotechnology, and/or or medical device industries.
• At least 10 years of increasing responsibility within Regulatory Affairs.
• At least 5 years of experience leading and managing a team.
• Direct experience with pharmaceutical regulatory submissions, including electronic submissions in the United States and Canada.
• A proven track record of effective collaboration with regulatory agencies, specifically the Food & Drug Administration, including the successful completion of New Drug Application(s) (NDA).
• For a remote hire, the ability to travel overnight up to 25%
  
  

Additional preferred qualifications:

• Regulatory Affairs Certification preferred.
• Experience related to Combination Products (drug + device) strongly preferred.
• Experience fulfilling government contracts strongly preferred.
  
  

Please complete candidate application for consideration. Additional questions can be directed to talentacquisition@kaleo.com.