Associate Director/Director for Regulatory Affairs

Padagis; United States; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Padagis US LLC is seeking an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies, submissions, and writing for US-market pharmaceutical products, including ANDAs for generics across various dosage forms.

The role requires leading regulatory initiatives across preclinical to manufacturing stages, coordinating with R&D, clinical affairs, quality, and manufacturing, and serving as the primary FDA liaison to ensure timely filings and approvals.

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• 7–10+ years in Regulatory Affairs in pharma/biotech.
• Proven track record leading ANDA/IND/NDA submissions with FDA.

Responsibilities

• Develop and implement regulatory strategies for US development programs.
• Lead preparation and submission of INDs, NDAs, and ANDAs to FDA.
• Coordinate with cross-functional teams for timely filings and reviews.
• Serve as primary FDA liaison and manage agency communications.
• Ensure compliance in launch, labeling, and post-approval activities.

Skills

Regulatory leadership

Project management

Communication

Education

Advanced degree in life sciences or pharmacy

Job description

Associate Director/Director for Regulatory Affairs

• Posted on August 25, 2026

Locations

Showing 1 location

Minneapolis, MN 55427, USA

+11 more locations

• Remote
• Travel Required : Yes
• Regulatory Affairs
• Full-Time
• Requisition #: ASSOC002047

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 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.

Job duties

• 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.

Required qualifications

• 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.

Preferred qualifications

• 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.

Padagis Core Competencies

• Service delivery – Understand who your internal and external customers are, identify their needs, and deliver value above their expectations…
• Active collaboration – Seek opportunities to work together across teams, function, business units, and geographies to seek success…
• Demonstrate agility – Proactively identify changes in our environment and act quickly, leading or embracing change…
• Think differently – Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists…
• Excellent execution – Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes…

About Us

At Padagis our focus is on health care products that improve people’s lives.We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products. It’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

Travel Required

Yes . 15% travel (mostly domestic) with 1-2 international trips yearly

Experience

2 years: Leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA.

7-10 years: Regulatory Affairs experience within the pharmaceutical or biotechnology industry

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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