Senior Director of Regulatory and Quality

Job Title: Senior Director of Regulatory and Quality Location: Remote Reports To: USA President and is member of the affiliate Management Team. This role has dotted reporting line to RA, QA & PV Global functional Heads. Role Summary The US Regulatory & Quality Senior Director leads the regulatory, quality and pharmacovigilance US responsibilities and team. They will serve as the primary local contact for FDA and other US Authorities, ensuring that the company complies with all applicable US regulatory (RA), quality (QP), and pharmacovigilance (PV) regulations. The Senior Director will be part of the global community and will work closely with their counterparts in global functions regarding regulatory strategy, quality standards and oversight, and safety validated systems to operate locally in accordance with company strategy, priorities, systems and processes and compliant with US requirements. The Senior Director acts on behalf of the NDA holder and collaborates closely with Global Regulatory Affairs, Quality Assurance and Pharmacovigilance, to maintain the lifecycle, compliance, and oversight of products commercialized in the United States. The Senior Director is responsible for ensuring the safety of US marketed pharmaceutical products by overseeing the monitoring, assessment, and reporting of adverse events throughout a drug’s lifecycle and guarantees compliance with FDA requirements, manage safety surveillance activities, and oversee operational pharmacovigilance processes both locally and globally. The role demands a solid balance of scientific expertise, regulatory knowledge, business experience, solid leadership skills, and trustable cross‑functional collaboration in a global /local setting.

Key Responsibilities

REGULATORY AFFAIRS

• Serve as the primary FDA point of contact for assigned NDAs, INDs, post-market commitments, and inspections. Acting as US agent for the company.
• Provide strategic input to global teams in preparing, submitting, and maintaining US regulatory filings, including annual reports, supplements and amendments, labelling updates, responses to FDA information requests, etc.
• Coordinate FDA communications, ensuring timely escalation to global teams.
• Maintain local regulatory intelligence on US requirements and standards; communicate changes proactively to headquarters.
• Ensure US-specific labelling, promotional materials, and advertising comply with FDA regulations (21 CFR 202.1) and company policies.
• Support launch readiness from a regulatory standpoint for new products entering the US market.

QUALITY

• Serve as the Designated Representative and the local Quality Representative

ensuring compliance with US distribution/Good Distribution Practices (GDP) and wholesale requirements.

• Coordinate quality activities between US distribution partners (3PL, warehouse, logistics) and Global Quality.
• Oversee local quality incidents (complaints, deviations, temperature excursions) and ensure timely reporting to global QA.
• Support product releases, batch verification, and supply chain controls as defined by the global Quality System.
• Support readiness for and hosting FDA inspections or partner audits in the US.
• Maintain oversight of US-based quality vendors and participate in qualification and monitoring activities.
• Promote Quality culture to all stakeholders in the affiliate.

PHARMACOVIGILANCE

• Drug Safety & Risk Management:
• Oversee drug safety surveillance before and after product launch to ensure patient safety and evaluate benefit–risk profiles.
• Develop, implement, and manage Risk Evaluation and Management Systems (REMS) and safety‑related documentation.

Case Processing & Regulatory Reporting

• Manage case processing activities for clinical and post‑marketing adverse events. Ensure compliance with FDA reporting requirements, international PV regulations, and internal SOPs.

PV System Oversight

• Organize, maintain, and continuously improve a high‑compliance PV System, including documentation, audits, and inspections.
• Monitor PV system performance and ensure compliance among external partners and distributors

Cross-functional Leadership & Communication

• Lead PV teams, coordinate global/regional PV activities, and represent PV in management discussions in the territory.
• Act as the primary resource for internal teams, healthcare professionals, inspectors, and regulators on safety‑related issues Audits & Inspections.
• Prepare for and lead internal and external PV audits and regulatory inspec

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