The role of Regulatory Project Leader is an active role to be based from either our Melbourne or Sydney offices.
The Regulatory Project Leader (RPL) is targeted at candidates with technical expertise and strong organisational and management skills.
Project Managers are responsible for leadership of major assignments and client relationships.
RPL’s will pull, organise and manage virtual teams from with the Regulatory Consulting and Submissions group in conjunction with Directors. The Regulatory Project Manager will be responsible for the quality and timeliness of assignment and are also responsible for providing advice and assistance to clients and other Kendle associates in their areas of expertise.

Accountable for the performance on major projects.
Working independently assisting clients with regulatory advice and strategies.
Providing general, development and regulatory advice to both clients and Kendle associates.
Responsible for leading designated projects and direction of team members to complete projects on time, to both cost and quality requirements (including QA of documentation as necessary).
Acting as primary point of contact for specific clients and regulatory authorities as required.
Arranging, leading and reporting on client meetings.
Arranging, leading and reporting on meetings with regulatory authorities.
Refining an area of special skill; providing an in-house resource in specific area of expertise.
Contributing to time and cost estimates for projects.
Assisting in training staff within Operating Units and Kendle globally as required.

Applications are invited from candidates who meet the following criteria:
Relevant Scientific Degree (or equivalent).
Demonstrated combined pharmaceutical and management related experience.
Experience in Regulatory and expertise at managing the preparation of regulatory submissions including IND, NDA, MAA, CTD and European clinical trial applications.
Experience working in an independent office environment, knowledge of the CRO industry, and strong management experience in a complex multi-process oriented environment in general is strongly desired.
Sound and current regulatory knowledge, with an understanding of the critical path of pharmaceutical product development.
In depth knowledge of specialty or broad general knowledge of registration and competence in all aspects of dossier production (QSE).
Attention to detail, flexibility with excellent organisational, verbal and written communication skills.
Ability to interact effectively with designated clients, and with staff from within Kendle as required.
Generation of new business via repeat business from existing clients or introduction of new clients, in specialised area.
Contribution to the performance review of other Kendle regulatory personnel as appropriate.
70% of work time spent on chargeable client projects.