Associate Regulatory Affairs Project Manager

Regulatory Affairs (RA) is responsible for the hands-on regulatory activities required to submit, approve, and launch new products and for the maintenance of existing commercial drug products. We are hiring an Associate RA Project Manager to be based at our Minneapolis, Minnesota location in New Hope, Minnesota.

Job duties:

• creating and revising product labeling
• creating and revising drug listings
• publishing eCTD compliant submissions
• managing and maintain regulatory information
• support manufacturing and procurement in the management of change to existing commercial products, identifying any changes necessary in regulatory filings
• prepare applications and technical files in support of existing commercial product regulatory maintenance
• develop and approve label specifications in compliance with SOPs
• maintain regulatory files and data systems in compliance with SOPs
• represent regulatory affairs in project meetings with both Perrigo staff and external contacts

Minimum qualifications:

• 4-year college/university degree in a related field
• two or more (2+) years of related experience

Key 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...
• 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.

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.