Associate Director/Director for Regulatory Affairs

Padagis•Minneapolis, MN

8d•Remote

About The Position

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 requitements 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, 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.

Requirements

Education: Advanced degree in life sciences, pharmacy, or a related field.
Experience: 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.

Nice To Haves

The ideal candidate would have at least 7 years of experience working in Regulatory Affairs, at successful generic pharmaceutical companies in the US, on ANDA submissions.

Responsibilities

Regulatory Strategy Development : Develop and implement comprehensive regulatory strategies to support the development phase according to the current FDA guidances and recent trends.
Provide regulatory leadership during all phases of product development, including preclinical, clinical, and manufacturing stages, ensuring alignment with FDA standards and guidelines.
Assess and mitigate regulatory risks, ensuring anticipated challenges are addressed proactively.
Regulatory Submissions and Approvals: Oversee the preparation, submission, and management of high-quality regulatory documentation, including INDs, NDAs, ANDAs, and amendments to the FDA.
Plan and execute submission timelines to ensure timely filings and approvals within project deadlines.
Collaborate with cross-functional teams, including R&D , Clinical Affairs, Quality, and Manufacturing, to compile, review, and finalize submission packages.
Communication and Liaison with FDA: Serve as the primary point of contact with the FDA for assigned development programs, ensuring a professional and transparent relationship.
Coordinate and facilitate meetings with the FDA, including Pre-IND, End-of-Phase, and Pre-NDA meetings, PDEV -meeting for ANDAs and Control Correspondences to ensure alignment with regulatory expectations.
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum.
Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation, advertising, promotional materials, and post-marketing surveillance.
Support the coordination of Risk Evaluation and Mitigation Strategies (REMS) and ensure compliance with post-approval regulatory commitments.
Regulatory Affairs Expertise and Leadership : 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.