Senior Manager, Regulatory and PV Delivery

This is a fully remote position, open to applicants in Australia.

📋 Description

• Act as the franchise liaison between Ergomed Group and clients across various project programs.

• Oversee and manage complex projects and regulatory deliverables.

• Coordinate and implement regulatory tasks while guiding teams to achieve targets and adhere to established procedures, trackers, and templates.

• Provide strategic insights to both internal and external clients.

• Identify and address risks through proactive measures.

• Resolve issues related to performance and delivery failures.

• Offer guidance to clients on intricate queries and updates in local regulations and guidelines.

• Engage in business development meetings and assist in acquiring new or repeat business.

• Develop and assess regulatory components of proposals, including regulatory costing and budgets.

• Cultivate professional relationships with both local and international internal and external stakeholders.

• Train, coach, and mentor junior staff; may also involve line management of staff.

• Assist in client qualification processes.

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

• Propel departmental and company initiatives, managing the implementation of change.

⛳️ Requirements

• At least 5 years of experience in the pharmaceutical or CRO industry or with a regulatory body.

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

• Demonstrated capability in successfully managing global projects.

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

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

• Practical experience with post-marketing regulatory activities and lifecycle management is highly valued.

🏝️ Benefits

• Option for remote work.

• Flexible working environment.

• Opportunities for growth.

• Collaborative team atmosphere.

• Opportunities for training, coaching, and mentoring.

• Global reach with chances to collaborate with international teams.