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.

• Drive deliverables in regulatory and pharmacovigilance according to established plans.

• Lead and represent projects of high complexity and their deliverables.

• Coordinate, manage, and execute regulatory tasks while guiding teams to achieve targets and adhere to procedures.

• Offer strategic insights to both internal and external stakeholders.

• Identify and mitigate risks through proactive measures.

• Address performance issues and resolve delivery failures.

• Provide guidance to clients on complex inquiries and alterations in local regulations and guidelines.

• Communicate project responsibilities and time allocations to team members.

• Oversee project budgets and escalate any out-of-scope activities.

• Engage in business development meetings and develop/review sections of regulatory proposals, including costings and budgets.

• Prepare client invoices and review/approve vendor project invoices.

• Offer training, coaching, and mentoring to junior team members.

• Assist in client qualification activities.

• Ensure readiness for audits and coordinate departmental representation during audits/inspections.

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

• Gather, quality-control review, and disseminate regulatory intelligence.

• Aid in interpreting legislation and conducting impact analyses.

• Cultivate professional relationships with both local and international contacts.

• Propel departmental and company initiatives and manage the implementation of changes.

⛳️ Requirements

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

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

• Demonstrated ability to successfully manage global projects.

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

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

• Capability to provide strategic regulatory advice.

• Proficiency in managing complex regulatory and pharmacovigilance deliverables.

• Ability to track project budgets, compare actual hours to budgeted hours, and identify/escalate out-of-scope work.

• Competence in supporting audits, inspections, client qualification activities, and regulatory intelligence efforts.

🏝️ Benefits

• Option for remote work.

• Flexible work environment.

• Opportunities for growth.

• Collaborative team atmosphere.

• Training, coaching, and mentoring opportunities.

• Professional development through involvement in company initiatives.

• Chance to contribute to patient safety and global pharmaceutical projects.