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 mandates.

• Propel regulatory and pharmacovigilance outcomes per established schedules.

• Engage in business development discussions and aid in the creation of proposals and budgets.

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

• Lead and represent projects and deliverables of high complexity.

• Organize and oversee regulatory tasks, teams, objectives, procedures, trackers, and templates.

• Provide strategic advice to both internal and external stakeholders.

• Identify, assess, and mitigate risks while addressing performance or delivery challenges.

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

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

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

• Assist in client qualification processes.

• Ensure readiness for audits and coordinate departmental involvement in audits and inspections.

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

• Gather, assess, and share regulatory intelligence.

• Aid in the interpretation and impact assessment of legislation.

• Cultivate professional relationships with local and international contacts.

• Propel department and organizational initiatives while managing change implementation.

⛳️ 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 oversee global projects.

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

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

🏝️ Benefits

• Flexible remote working options.

• Opportunities for training, coaching, and mentorship.

• Collaborative team setting.

• Opportunities for professional growth.

• A global work atmosphere.

• A supportive culture centered on kindness, flexibility, growth, and inclusion.