Regulatory Affairs Director: FDA Submissions (Remote)

Padagis; United States; Hybrid; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory leadership

Project management

Communication

Ausbildung

Advanced degree in life sciences or pharmacy

Jobbeschreibung

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.