Director, Enterprise Regulatory Compliance

Scorpion Therapeutics; Raritan (NJ); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Vacation 120h/yr

Sick time 40h/yr

Floating holidays

Personal time

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Military spouse time-off

Job summary

Scorpion Therapeutics, based in New Jersey, seeks an Enterprise Regulatory Compliance leader to act as the single point of contact for policy interpretation and issue triage across pharmaceutical and medical device businesses.

You will review inspections, support readiness for Health Authority audits, assess risks, and guide senior leadership on compliance strategy, including AI governance and data governance aligned with privacy and responsible AI.

Qualifications

• Bachelor’s degree required; advanced degree or certification preferred.
• 10+ years relevant quality and compliance experience required.
• cGMP regulatory compliance experience in medical devices and/or pharmaceuticals required.
• Health Authority/Notified Body experience preferred.
• Strong written/oral communication; leadership track record; ability to influence across cultures/functions; travel up to 20%.

Responsibilities

• Serve as Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of global regulations, company standards, and policies.
• Review and classify Health Authority inspections and corporate cGMP audits; review and initiate issue management for inspections and recalls.
• Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
• Review US FDA response reviews for completeness, quality, and alignment.
• Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
• Build AI literacy and apply approved AI-enabled tools consistent with data governance, privacy, and responsible AI expectations.
• Lead governance for significant compliance escalations; align required actions and communications to senior leadership.
• Participate in corporate compliance audits, due diligence, and acquisition compliance assessments.
• Provide consultative expertise on compliance issue management and health authority responses/field actions.
• Provide cGMP training on risk-based auditing strategies.

Skills

Leadership

Regulatory compliance

cGMP knowledge

Communication

Data analytics

Education

Bachelor's degree

Advanced degree preferred

Tools

AI literacy

Job description

Responsibilities:

• Serve as Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.


• Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of global regulations, company standards, and policies.


• Review and classify Health Authority inspections and corporate cGMP audits; review and initiate issue management for inspections and recalls.


• Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.


• Review US FDA response reviews (as assigned) for completeness, quality, and alignment.


• Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.


• Build AI literacy and apply approved AI-enabled tools consistent with data governance, privacy, and responsible AI expectations.


• Lead governance for significant compliance escalations; align required actions and communications to senior leadership.


• Participate in corporate compliance audits, due diligence, and acquisition compliance assessments.


• Provide consultative expertise on compliance issue management and health authority responses/field actions.


• Provide cGMP training on risk-based auditing strategies.

Qualifications:

• Bachelor’s degree required; advanced degree or certification preferred.


• 10+ years relevant quality and compliance experience required.


• cGMP regulatory compliance experience in medical devices and/or pharmaceuticals required.


• Health Authority/Notified Body experience preferred.


• Strong written/oral communication; leadership track record; ability to influence across cultures/functions; thrive in a complex matrix; up to 20% travel.

Preferred skills:

• Advanced analytics; audit/compliance trends; compliance management and risk; confidentiality; internal auditing; investigation techniques; policy development; report writing; tactical planning; technical credibility.

Benefits (time off):

• Vacation: 120 hours/year; Sick time: 40 hours/year (CO 48; WA 56); Floating holidays/holiday pay: 13 days/year; Work/personal/family time: up to 40 hours/year; Parental leave: 480 hours; Bereavement leave: 240 hours immediate family (40 hours extended family); Caregiver leave: 80 hours (52-week rolling) / 10 days; Volunteer leave: 32 hours; Military spouse time-off: 80 hours/year.