[Hiring] Associate Director/Director of Regulatory Affairs @Padagis LLC

Role Description

Padagis US LLC is seeking an experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible for overseeing regulatory strategies, submission requirements, and writing for pharmaceutical products targeted for the U.S. market. Majority of the submissions are ANDAs for generic products in a variety of dosage forms such as complex oral solids, injectables, transdermal, and sterile ointments. In this pivotal role, you will work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance, provide consultation on regulatory aspects during the development phase, and ensure all activities are planned and executed for a successful submission. This position plays a critical role in guiding products through the development pipeline, securing FDA approval, and establishing a strong foundation for market entry.

Note: This is a remote workplace eligible position for candidates residing in the United States, with preference given to candidates in the Minneapolis-St. Paul, Minnesota area.

Qualifications

• Advanced degree in life sciences, pharmacy, or a related field.
• 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Proven track record of leading and successfully managing ANDA, IND, NDA submissions and approvals with the FDA.
• Experience in regulatory strategy planning for generic drugs and combination products.
• Strong knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions.
• Exceptional project management skills with the ability to manage multiple priorities and deadlines.
• Strong analytical and problem-solving skills with a proactive and solutions-oriented mindset.
• Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies.

Requirements

• Stay current with evolving FDA regulations, guidances, and industry trends to ensure compliance and improve internal regulatory processes.
• Provide mentorship, training, and guidance to junior regulatory staff and help cultivate a high-performing regulatory team.
• Represent the Regulatory Affairs function in internal and external meetings, providing strategic insights to support business and development goals.

Benefits

• Remote workplace eligible position.
• Opportunity to work in a dynamic environment with a focus on health care products that improve people’s lives.
• Be part of a market-leading generic prescription pharmaceutical company with a high growth trajectory.