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 standards.

• Propel regulatory and pharmacovigilance outcomes in accordance with predefined plans.

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

• Oversee and direct high-complexity initiatives and deliverables.

• Organize and carry out regulatory responsibilities while ensuring compliance with targets and protocols.

• Provide strategic insights to both internal and external stakeholders.

• Recognize and mitigate risks through proactive measures.

• Address performance challenges and resolve delivery issues.

• Counsel clients on intricate inquiries and modifications in local regulations and guidelines.

• Track project assignments, budgets, hours utilized versus projected, and escalate issues beyond the scope.

• Engage in business development discussions and contribute to the creation or review of regulatory proposal sections, cost estimates, and budgets.

• Prepare and assess client invoices as well as approve vendor project invoices.

• Assist in client qualification processes.

• Ensure readiness for audits and take part in audits and inspections.

• Prepare or contribute to the Regulatory Newsletter and update the regulatory database.

• Gather, review for quality, and disseminate regulatory intelligence.

• Aid in the interpretation and impact analysis of legislation.

• Cultivate professional relationships with internal and external contacts worldwide.

• Lead department and company initiatives while managing change implementations.

⛳️ Requirements

• A minimum of 3 years of experience in the pharmaceutical or CRO industry, or a regulatory body.

• At least 3 years in a leadership or project management capacity.

• Demonstrated ability to effectively manage global projects.

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

• Comprehensive understanding of pertinent legislation and local requirements for areas of expertise.

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for growth and professional development.

• Collaborative team atmosphere.

• Training, coaching, and mentoring opportunities available.

• Exposure to global work environments.

• A supportive culture prioritizing kindness, flexibility, growth, and a sense of belonging.