Remote Associate Director, Regulatory Affairs – ANDA Strategy

Padagis-LL; Minneapolis (MN); Vor Ort; USD 140.000 - 230.000; Vollzeit

Zusammenfassung

Padagis US LLC is seeking an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies, submissions, and FDA interactions for U.S. market products, including ANDAs for generic dosages.

This remote-position is eligible for candidates in the United States with a preference for Minneapolis–St. Paul area, and requires collaboration across R&D, Quality, and Manufacturing to ensure timely, compliant filings and market entry.

Qualifikationen

• Education: Advanced degree in life sciences, pharmacy, or related field.
• Experience: 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Proven track record of leading ANDA, IND, NDA submissions and approvals with the FDA.
• Experience in regulatory strategy planning for generic drugs and combination products.

Aufgaben

• Develop and implement regulatory strategies to support development phases per FDA guidances.
• Provide regulatory leadership across preclinical, clinical, and manufacturing stages.
• Oversee preparation and submission of INDs, NDAs, ANDAs and amendments to FDA.
• Plan submission timelines and coordinate with R&D, Clinical, Quality and Manufacturing teams.
• Serve as primary FDA contact for development programs and facilitate meetings.
• Ensure regulatory compliance in launch preparation, promotional materials, and post-marketing activities.

Ausbildung

Advanced degree in life sciences, pharmacy, or related field

Jobbeschreibung

Padagis US LLC is seeking an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies, submissions, and FDA interactions for U.S. market products, including ANDAs for generic dosages.

This remote-position is eligible for candidates in the United States with a preference for Minneapolis–St. Paul area, and requires collaboration across R&D, Quality, and Manufacturing to ensure timely, compliant filings and market entry.