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.

• Drive the execution of regulatory and pharmacovigilance objectives according to established plans.

• Engage in business development discussions and assist in creating proposals and budgets.

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

• Lead and represent complex projects and deliverables.

• Coordinate and oversee regulatory activities, guiding teams to achieve targets and adhere to procedures, trackers, and templates.

• Provide strategic insights to both internal and external stakeholders.

• Identify and mitigate risks through proactive measures.

• Address performance issues and rectify delivery shortcomings.

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

• Monitor project budgets and hours against forecasts, highlighting any out-of-scope concerns.

• Create and review regulatory proposal sections, cost estimates, and budgets.

• Prepare client invoices and evaluate or authorize 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.

• Support the analysis and interpretation of legislative impacts.

• Cultivate professional relationships with global internal and external contacts.

• Lead departmental and company initiatives while managing the implementation of change.

⛳️ Requirements

• At least 3 years of experience in the pharmaceutical, CRO industry, or a regulatory agency.

• Minimum of 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 applicable legislation and local requirements for areas of expertise.

🏝️ Benefits

• Flexible working arrangements.

• Opportunities for growth.

• Collaborative and supportive work atmosphere.

• Professional development through training, coaching, and mentoring.

• Global team with international exposure.

• Chance to contribute to company initiatives and implement changes.

• Purpose-driven work focused on patient protection.

• A diverse and inclusive workplace.

• A passionate and collaborative team of experts.