Planning & Compliance Manager - Regulatory Affairs (AP RMC)

Job description

· Regional Regulatory Compliance role
· 12-month contract role
· North Ryde based
Be vital In this role…

If you are excited by and have experience in regulatory affairs, quality assurance or regulatory compliance specifically with prescription medicines or in generics and would like to be exposed to a broad range of therapy areas, this role is for you.

The role will be part of the Asia Pacific Regional Management Centre (RMC) based in Sydney. The RMC, led by senior regional regulatory staff, is responsible for the submission of post-approval CMC variations and labelling changes, and all associated compliance and tracking activities associated with these submissions.

Reporting to the Asia Pacific RMC Head, the Planning & Compliance Manager drives integrated planning to enable the RMC to achieve deliverables with optimal resourcing. They will be responsible for the maintenance and compliance of the RMC planning tool and integrating submission planning from global, regional, and local regulatory affairs, and accountable for Asia Pacific compliance metrics reported to global senior regulatory leadership. The incumbent will be accountable to engage stakeholders throughout the process to define best fit planning and assign submissions to RMC staff and monitor progress. In this role the Planning & Compliance Manager will be the single point of contact for Global teams on planning, prioritization, escalation, in which he/she closely aligns with the RMC head. Together with the RMC team, he or she will seek continuous improvement of the processes and propositions.

Desired profile

Qualifications :

Be valued for who you are:
·  Minimum Bachelors' degree in pharmacy, life sciences or equivalent field
·  Minimum of 5 years of project management / resource planning experience
·  Minimum of 3 years of regulatory experience
·  Demonstrated organizational skills, complex project management skills, as well as experience working in a matrix organization
·  Knowledge of local and regional regulations/legislation (preferred)
·  Experience in working with limited supervision and able to make independent decisions
·  Excellent verbal and written communication skills – proficiency in written and oral English
·  Ability to communicate to senior level management


Be part of something bigger than yourself…

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.

Please apply online using the link below. You will receive an automated email confirming receipt of your application. Every application is reviewed by the Talent Acquisition team and candidates will receive notification of the outcome of their application in a timely manner.

Agencies please note: this recruitment assignment is being managed directly by Johnson & Johnson's Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.

The closing date for applications is 5 th April 2018.