Regulatory Affairs Manager

THE COMPANY YOU WOULD BE JOINING

• Established in the 1990’s, this organisation is an Australian owned pharmaceutical manufacturer who supports the health of Australians by supplying over 60 medicines in critical therapeutic areas.
• Together with manufacturing medicines, they collaborate with hospitals in developing sought after treatment solutions with a focus on hospital specialty pharmaceuticals.

THE BENEFITS TO YOU

• Career opportunities exist here if you are seeking professional growth.
• This company is committed to protecting and improving the environment. To dramatically reduce its carbon footprint, they are implementing wide ranging and innovative energy efficiency initiatives.
• An equal opportunity employer, this organisation is driven by upholding strong values.
• Empowering and supportive manager, who encourages shared ideas and opinions in a collaborative environment.
• This Regulatory Affairs Manager role will expand your scope and career in a pharma manufacturing environment.

WHAT YOU WILL LEAD AND MANAGE

• This Regulatory Affairs Manager role, based on Sydney’s North Shore, is primarily to oversee the company’s daily Regulatory Affairs activities, with management responsibility, for senior Regulatory Affairs associates and Regulatory Affairs associates, 6 in team.
• This position is responsible for the oversight of preparation, submission and maintenance of the company’s product dossier registrations and licensing requirements.
• Additionally, it will be necessary to liaise with the Regulatory Affairs staff of partner companies in other countries to assist with the strategy, finalisation, approval and maintenance of licences in these territories.
• The Regulatory Affairs Manager will take on responsibility for mentoring less experienced members of staff and will assist with their development, providing opportunities and advice wherever possible.
• The activities associated with this role are of a highly skilled and technical nature requiring a depth of experience that would allow the person to be a vital resource for the company in all aspects of the role as well as other GMP issues that may impinge on the Regulatory Affairs function, specifically in the areas of quality control and manufacturing.
• The key performance areas for this role are; Regulatory Affairs, Regulatory Compliance and Leadership/Mentoring.

WHAT YOU WILL NEED TO BE SUCCESSFUL

• University degree in science or similar with experience in a Regulatory Affairs Manager role, within the pharmaceutical industry.
• Experience with the TGA & other regulatory bodies/authorities for registration of products.
• Experience in reviewing submissions to regulatory bodies/authorities generated by RA associates.
• Experience in generating applications and dossiers for submission to regulatory authorities.
• Full Australian working rights only.

Interested? Please 'apply now' quoting reference number 3595 or call Nicole Villanueva on 0414.919.461. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.
Additional information

• Parking on site on Sydney's lower north shore
• Seeking professional growth?
• Supportive, encouraging manager, shared ideas, collaborative team