Senior Director, Regulatory Affairs

Scorpion Therapeutics; Waltham (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Ardelyx seeks a Senior Director of Regulatory Affairs to develop and execute global regulatory strategies across its product portfolio, supporting both pipeline and marketed therapeutics. You will lead regulatory planning from early development through post-approval and manage interactions with FDA, EMA, and other authorities.

You will oversee IND/CTA, BLA/NDA, and MAA submissions, ensure readiness and compliance, and provide strategic guidance on trial design, regulatory pathways, and risk

Qualifications

• Bachelor's degree in life sciences or related field.
• 12+ years of regulatory experience in pharma/biotech with a proven track record in BLA/NDA/MAA submissions.
• Deep expertise in FDA regulations (21 CFR, ICH), with knowledge of EMA and global frameworks.
• RAC certification (preferred).
• Global regulatory experience and familiarity with expedited pathways like Breakthrough Therapy or Fast Track.

Responsibilities

• Lead regulatory planning for early development through post-approval.
• Manage interactions with FDA, EMA, and other authorities.
• Oversee IND/CTA, BLA/NDA, and MAA submissions.
• Ensure regulatory compliance and readiness.
• Collaborate with Clinical Development, Medical Affairs, and leadership on trial design, regulatory pathways, and risk management.
• Lead and mentor the regulatory team and communicate regulatory impact to stakeholders.

Skills

Regulatory strategy

FDA

Leadership

Stakeholder management

IND/CTA

BLA/NDA

Education

Bachelor's degree in life sciences

Job description

Senior Director of Regulatory Affairs responsible for developing and executing global regulatory strategies across Ardelyx's product portfolio, supporting pipeline and marketed therapeutics.

Responsibilities

• lead regulatory planning for early development through post-approval
• manage interactions with FDA, EMA, and other authorities
• oversee IND/CTA, BLA/NDA, and MAA submissions
• and ensure regulatory compliance and readiness.
• Collaborate with Clinical Development, Medical Affairs, and leadership, providing strategic guidance on trial design, regulatory pathways, and risk management.
• Lead and mentor the regulatory team, monitor evolving regulatory landscapes, and communicate impact to stakeholders.

Requirements

• bachelor's degree in life sciences or related field
• 12+ years of regulatory experience in pharma/biotech, with a proven track record in BLA/NDA/MAA submissions.
• Deep expertise in FDA regulations (21 CFR, ICH), with knowledge of EMA and global frameworks.
• Strong leadership, strategic thinking, and stakeholder management skills
• RAC certification (preferred).
• High-Value: experience with biologics, small molecules, gene therapy, or combination products
• global regulatory experience
• familiarity with expedited pathways like Breakthrough Therapy or Fast Track
• working knowledge of international regulations.

Work setup: not specified.