Manager, Regulatory and PV Delivery

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Formulate strategies in alignment with regulatory requirements

• Oversee regulatory and pharmacovigilance outputs in accordance with the established PV and regulatory frameworks

• Support senior management in acquiring new business through active participation in BDM and contributions to proposals and budgets

• Offer strategic regulatory advice, training, coaching, and mentorship to junior team members

• Lead and represent intricate projects and deliverables

• Organize, manage, and implement regulatory tasks while guiding teams to achieve objectives and adhere to procedures

• Provide strategic insights to both internal and external stakeholders

• Identify risks and implement preventive measures to address them

• Resolve performance-related issues and failures in delivery

• Counsel clients on complex inquiries and modifications in local regulations and guidelines

• Track project tasks, budgets, and hours against financial plans; recognize and escalate out-of-scope work

• Create and review regulatory components of proposals, regulatory cost estimates, and budgets

• Prepare client invoices and review or authorize vendor project invoices

• Assist in client qualification processes

• Ensure readiness for audits and coordinate departmental involvement in audits and inspections

• Draft or contribute to the Regulatory Newsletter and update the regulatory database

• Collect, review for quality, and disseminate regulatory intelligence

• Aid in the interpretation and impact assessment of legislation

• Cultivate professional relationships with both local and international contacts

• Propel departmental and corporate initiatives while managing the implementation of changes

⛳️ Requirements

• At least 3 years of experience in the pharmaceutical or CRO industry, or within a Regulatory body

• Minimum of 3 years in a leadership or project management capacity

• Demonstrated success in managing global projects

• In-depth knowledge of ICH GCP and/or GVP

• Comprehensive understanding of relevant legislation and local requirements for areas of expertise

🏝️ Benefits

• Availability for remote work

• Flexible working environment

• Opportunities for growth

• Collaborative team culture

• Options for training, coaching, and mentorship

• Exposure to global and international work

• Chance to contribute to impactful patient-safety initiatives