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.\nProvide regulatory leadership during all phases of product development, including preclinical, clinical, and manufacturing stages, ensuring alignment with FDA standards and guidelines.\nAssess and mitigate regulatory risks, ensuring anticipated challenges are addressed proactively.\n

Regulatory Submissions and Approvals:

Oversee the preparation, submission, and management of high-quality regulatory documentation, including INDs, NDAs, ANDAs, and amendments to the FDA.\nPlan and execute submission timelines to ensure timely filings and approvals within project deadlines.\nCollaborate with cross-functional teams, including R D , Clinical Affairs, Quality, and Manufacturing, to compile, review, and finalize submission packages.\nCommunication 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.

\nRespond to FDA queries and requests in a timely and accurate manner to maintain project momentum.\nCollaborate with cross-functional teams to ensure regulatory compliance in launch preparation, advertising, promotional materials, and post-marketing surveillance.\nSupport 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.\nProvide mentorship, training, and guidance to junior regulatory staff and help cultivate a high-performing regulatory team.\nRepresent 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.\n

Experience:

7-10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.\nProven track record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA.\nExperience 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:

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five \"core\" competencies. We strive to bring employees on board the journey with us who exemplify these key competencies: Service delivery

Understand who your internal and external customers are, identify their needs, and deliver value above their expectations...\nActive collaboration
Seek opportunities to work together across teams, function, business units, and geographies to seek success...\nDemonstrate agility
Proactively identify changes in our environment and act quickly, leading or embracing change...\nThink differently
Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists...\nExcellent 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.

What's Next:

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates. Qualifications\nExperience\n2 years: Leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA. (required)\n7

10 years: Regulatory Affairs experience within the pharmaceutical or biotechnology industry (required)\nEqual Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws.

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