Global R&D Compliance Lead - Associate Director

Galderma; Boston (MA); Vor Ort; USD 170.000 - 212.000; Vollzeit

Zusammenfassung

Galderma is seeking an Associate Director, Global R&D Compliance Lead to manage compliance support for the global R&D organization from our Boston hub. The role advises on risk areas, coordinates governance with the R&D Legal group, and reports to the Global Head of Ethics & Compliance.

The candidate will lead training, oversee FMV and Investigator Initiated Studies processes, and collaborate with Global Medical Affairs to ensure adherence to US and international regulations.

Qualifikationen

• Bachelor’s Degree required; lawyer qualification strongly preferred.
• 7+ years of experience advising pharmaceutical, biotechnology or medical device company on compliance matters, with 3 years in-house preferred.
• Strong understanding of healthcare compliance and regulatory framework in pharma/medical devices.
• Significant experience advising R&D organizations on R&D and related matters.
• Expertise advising on U.S. and international healthcare compliance for prescription products and devices.

Aufgaben

• Serves as the primary compliance point of contact for the R&D organization (including Global Medical Affairs).
• Oversees the R&D compliance program ensuring alignment with regulator expectations and Galderma’s policies.
• Manages research and consultancy arrangements with KOLs ensuring visibility and oversight of in-market spend.
• Supports governance related to Investigator Initiated Studies, clinical trials, and research funding requests.
• Leads training of global R&D personnel on compliance policies and procedures.
• Monitors regulatory changes and updates relevant policies and processes.

Kenntnisse

Healthcare compliance

R&D compliance

Regulatory knowledge

Policy development

Ausbildung

Bachelor’s Degree

J.D. / Lawyer qualification

Jobbeschreibung

Galderma is seeking an Associate Director, Global R&D Compliance Lead to manage compliance support for the global R&D organization from our Boston hub. The role advises on risk areas, coordinates governance with the R&D Legal group, and reports to the Global Head of Ethics & Compliance.

The candidate will lead training, oversee FMV and Investigator Initiated Studies processes, and collaborate with Global Medical Affairs to ensure adherence to US and international regulations.