Specialist, Regulatory Affairs

Kaléo•Richmond, VA

8h•Hybrid

About The Position

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 Specialist, Regulatory Affairs works as part of a team of professionals responsible for achieving regulatory approval and maintaining regulatory compliance for Kaléo’s products. The Specialist will contribute to regulatory strategies and obligations including audits/inspections, labeling, promotional materials, regulatory dossiers, study reports. At Kaléo, you will have broad scope to gain experience with all Regulatory Affairs functions. Our team works with products from conception, performing a regulatory gap analysis, through product development, culminating in the submission and review of a New Drug Application. Upon approval, the regulatory team works with various stakeholders to support all post-approval regulatory obligations, including compliance activities. On any given day, you will be working across a spectrum of regulatory issues for both drug and device regulations. You will be part of a close-knit, fiercely collaborative team that takes pride in being the best at what they do. You will have the opportunity to use your existing skills while continuing to learn and develop in a cross-functional, supportive environment.

Requirements

A bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
At least two years of laboratory, regulatory, or quality experience in the pharmaceutical, biotechnology, or medical device industries.
Proficiency with Electronic Common Technical Document (eCTD) software.
Proficiency with Microsoft Office Suite.
Proficiency with Adobe Acrobat.
The ability to work from home and occasionally be onsite.
Excellent organization skills and attention to detail.
Strong communication skills, including verbal and written communication.
The ability to review and summarize scientific and technical data, including regulatory standards.
The ability to thrive in a fast-paced environment, managing competing deadlines and priorities on a weekly basis.
Flexibility and adaptability to changing priorities, environments, and expectations.
Dedicated growth mindset, with the desire to continue to learn.
A commitment to participating in an inclusive workplace.
Developing intellectual curiosity and the desire to be part of an innovative organization.

Nice To Haves

Located in Richmond, VA preferred.

Responsibilities

Contributes to regulatory compliance for Kaléo’s commercial and development products.
Manages and conducts regulatory dossier compliance activities.
Participates in company-specific inspection readiness activities and FDA inspections.
Develops and updates product labeling and related materials to maintain compliance with current regulatory standards and expectations.
Collaborates on the development of strategic governance and compliance improvement programs, as needed.
Coordinate and manage timely submission of development and post-product approval materials to regulatory authorities and government partners.
Assesses the impact of new/updated regulatory standards and guidances and communicates the potential impact to applicable stakeholders.
Participate with team members in drafting and submitting regulatory dossiers.
Assist in implementing regulatory strategies for new development and post-approval projects.
Serve as Regulatory Affairs representative in internal meetings and cross-functional teams.
Assess design and manufacturing changes, test protocols, and reports.
Support periodic communication with regulatory authorities.
Assist in developing and maintaining Regulatory Affairs department procedures, vendor invoices, and agreements.