Manager, Regulatory and PV Delivery

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

📋 Description

• Create regulatory strategies in alignment with regulatory requirements.

• Oversee regulatory and pharmacovigilance outcomes in accordance with established plans.

• Lead and represent intricate projects and their deliverables.

• Organize, manage, and execute regulatory responsibilities.

• Motivate teams to achieve set goals 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 resolve delivery setbacks.

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

• Monitor project budgets, hours expended, and out-of-scope activities.

• Engage in business development meetings, preparing proposals, regulatory costing, and budgets.

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

• Offer training, coaching, and mentorship to junior personnel.

• Assist in client qualification processes.

• Ensure audit readiness and facilitate departmental audit involvement and responses.

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

• Gather, conduct quality-control reviews, and disseminate regulatory intelligence.

• Support the interpretation and impact assessment of legislation.

• Cultivate professional relationships with internal and external contacts globally.

• Propel department and company initiatives while managing change implementation.

⛳️ Requirements

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

• Minimum of 3 years in a leadership or project management position.

• Demonstrated capability 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.

🏝️ Benefits

• Remote work options available.

• A culture of kindness, flexibility, growth, and belonging.

• Opportunities for training, coaching, and mentoring.

• A collaborative team environment.

• Global reach with opportunities for professional growth.