Director, Regulatory Affairs

In addition to our commercial portfolio, Kaléo has secured multiple contracts with the U.S. government for production of new medical countermeasures, with commercialization opportunities to follow. The Director, Regulatory Affairs will serve in a dual role focusing on new product development programs and oversite of all nonclinical work executed on Kaléo’s behalf by vendors and CROs. This person will have a critical role in the successful execution of these projects as a management-level leader within Regulatory Affairs, reporting directly to the head of the Regulatory Affairs team, and working closely with Kaléo's Chief Development Officer. 

Responsibilities for this role will include strategic leadership at the management-level within assigned functional areas, pre-market regulatory strategy and compliance (post-market as needed), and direct interaction with external regulatory CROs/consultants, partners (e.g. U.S, Department of Defense), the US FDA, and other regulatory bodies. The Director will also serve as an internal regulatory affairs subject matter expert (SME) on investigational programs and development. Ownership of nonclinical oversite in this role will involve overseeing vendors and CROs on nonclinical development plans, assessing risks, managing budgets and FDA approval strategies, overseeing expert consultants in nonclinical technical areas and facilitating the execution of nonclinical studies.

At Kaléo, you will have direct responsibility for assets within the development portfolio and will work collaboratively with all levels of Regulatory Affairs and Development. On any given day, you will work across a spectrum of regulatory and nonclinical issues for both drug and device regulations. Regulatory Affairs plays a key role in planning the development of new products here. You will be part of a close-knit, fiercely collaborative team that takes pride in being the best at what they do. Kaléo’s “remote-first” culture will offer you the flexibility to choose your work location and schedule, placing an emphasis on self-management and adherence to deadlines. At Kaléo, you can feel confident that your work has a tangible impact.  

As Director, Regulatory Affairs, you will hold responsibilities in the following areas:

Regulatory Strategy

• Maintain knowledge of new regulatory requirements and interpret existing requirements as they relate to Kaleo’s products, procedures, testing, and record 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 accelerated pathways (i.e., Breakthrough designation, Fast Track, Priority Review), and Emergency Use Authorization.

Regulatory Affairs 

• Lead interactions with personnel at regulatory agencies, partners (corporate and government), and vendors. 
• Lead regulatory meetings: own preparation of meeting packages, meeting logistics, preparation of subject matter experts, and overall meeting leader. 
• 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 with regulations. 
• Advise on international product registration and import/export approval requirements. 
• Ensure compliance with PDUFA prescription drug program fee payment.

Nonclinical

• Work with consultants to identify study types and requirements for development programs and develop nonclinical program strategy.
• Manage consultants, CROs and associated budgets. ·
• Qualify labs as needed.
• Review and approval protocols and reports. 
• Oversee study execution.
• Accountable for Nonclincial Policies and Standard Operating Procedures to facilitate compliance with regulations.

A successful Director, Regulatory Affairs will have:

• Impeccable attention to detail and commitment to flawless execution of regulatory submissions and other critical work product.
• Demonstrated leadership skills, including the ability to think strategically, excellent interpersonal communication, and the desire and ability to develop and motivate teammates at all levels.
• Proven ability to excel in a fast-paced environment and manage competing priorities.
• A results-driven and outcome-oriented approach to work.
• Strong analytical skills, with the ability to evaluate technical data, review reports, and synthesize information with a regulatory mindset.
• The ability to impactfully communicate complex information to broad internal stakeholders and external partners. 
• Strong intellectual curiosity and desire to be part of an innovative organization. 
• Commitment to inclusivity at the team and organization level.

To be considered for the position, you must have:

• Degree in a scientific discipline.
• At least 8 years of increasing responsibility in the pharmaceutical, biotechnology, and/or or medical device industries.
• A least 5 years of increasing responsibility specifically within regulatory affairs, with at least 3 years managing assigned areas independently.  
• Direct experience with pharmaceutical regulatory submissions, including electronic submissions in the United States.
• Experience with all aspects of regulatory affairs from pre-clinical through post-marketing.
• Experience in reviewing nonclinical strategies, protocols and reports.
• Ability to travel up to 25%.
• 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).

Preferred qualifications:

• Advanced degree strongly preferred (PhD level).
• Regulatory Affairs Certification preferred. 
• Drug/device combination product experience preferred.
• Experience working on government contracts preferred.

Application required for consideration. Please contact talentacquisition@kaleo.com with any additional questions.