Manager, Regulatory and PV Delivery

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

📋 Description

• Formulate regulatory strategies aligned with regulatory requirements.

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

• Lead and represent intricate projects and their deliverables.

• Organize and oversee regulatory activities, driving teams to achieve targets and adhere to procedures.

• Offer strategic insights to both internal and external stakeholders.

• Recognize and address risks while resolving performance or delivery challenges.

• Counsel clients on complex inquiries and adaptations in local regulations and guidance.

• Track project budgets, time allocation, and out-of-scope work.

• Engage in business development discussions and craft proposals, regulatory cost assessments, and budgets.

• Generate client invoices and review or authorize vendor project invoices.

• Facilitate training, coaching, and mentoring for junior team members.

• Assist in client qualification processes and ensure audit preparedness.

• Create regulatory newsletters and maintain regulatory databases.

• Gather, validate, and distribute regulatory intelligence.

• Aid in the interpretation and impact assessment of legislation.

• Cultivate professional relationships with both internal and external contacts.

• Propel departmental and organizational initiatives while managing change implementation.

⛳️ 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 success in managing global projects effectively.

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

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

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for growth.

• A collaborative and supportive team culture.

• Training, coaching, and mentoring opportunities available.

• Exposure to global initiatives and purpose-driven work.

• A workplace culture focused on belonging.