Senior Specialist, Regulatory Affairs

Kaléo • Richmond, VA

1d

About The Position

Kaléo has secured multiple contracts with the U.S. government for production of new medical countermeasures, with commercialization opportunity to follow. The Senior Regulatory Affairs Specialist will have a critical role in the successful execution of these projects by managing and executing the overall Regulatory Affairs programs necessary to achieve and maintain worldwide regulatory investigational and marketing approval for Kaleo's products. This role shares responsibility to help ensure that all applicable regulatory obligations are submitted to competent authorities in compliance with applicable Regulations. At Kaléo, you will have broad scope to gain experience with all Regulatory Affairs functions. Our small team works with products from conception, performing a regulatory gap analysis, through product development (IND stage), culminating in the submission and review of a New Drug Application (NDA). Upon approval, the regulatory 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. 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

• 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.
• 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 fostering an inclusive workplace.
• Developing intellectual curiosity and the desire to be part of an innovative organization.
• A bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
• At least 5 years of laboratory, regulatory, or quality experience in the pharmaceutical, biotechnology, or medical device industries.
• Specialist knowledge in US Regulatory Affairs and industry best practices
• Proficiency with Electronic Common Technical Document (eCTD) software.
• Proficiency with Microsoft Office Suite.
• Proficiency with Adobe Acrobat.
• Experience submitting to regulatory agencies, including NDAs.

Nice To Haves

• Experience with combination products (drug / device) preferred.
• Regulatory Affairs Certification (RAC) strongly preferred.

Responsibilities

• Develops and implements regulatory strategies to facilitate the progress of programs in all phases of development.
• Prepare annual reports, supplements, amendments, and change notifications to regulatory agencies and ensure periodic reports are submitted to regulatory dossiers.
• Participate with team members in drafting and submitting dossiers in different regions around the world, including Chemistry, Manufacturing, and Controls (CMC); nonclinical; human factors; clinical; and pharmacovigilance activities.
• Assist in drafting and reviewing product labeling.
• Review clinical and non-clinical study protocols and other documentation, and assess clinical study related changes to determine regulatory impact.
• Review human factors study protocols and other human factors documentation.
• Support regulatory audits, as required.
• Assist in developing and maintaining Regulatory Affairs department procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level