Parking on site on Sydney's lower north shore
Are you an RA Associate wanting to step up to a Senior RA Assoc. role?
Do you have a med info, drug safety or RA background?

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 Senior Regulatory Affairs Associate role will suit someone who is currently in a RA Associate role looking to step up or a Senior RA Associate, looking for a role that will expand your scope and career in a pharma manufacturing environment.

WHAT YOU WILL LEAD AND MANAGE

This Senior Regulatory Affairs Associate role forms an essential part of the Regulatory Affairs team. The position will be responsible for the management of various regulatory activities, including preparation of submissions for, and liaison with, Australian regulatory authorities.
You will also have involvement in determining the strategic elements of submissions and will take responsibility for developing and drafting critical documents and 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.
This role will take on some responsibility for mentoring less experienced members of staff and will assist with their development, providing opportunities and advice wherever possible.
The opportunity to manage the department in the event of the absence of the Regulatory Affairs Manager will provide professional growth for the successful person.
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.

WHAT YOU WILL NEED TO BE SUCCESSFUL

University degree in science, pharmacy or similar (preferred but not essential) with experience in a Senior Regulatory Affairs Associate or Regulatory Affairs Associate role, within the pharmaceutical industry, in Australia, you MUST have Australian experience in the pharma industry with prescription medicines, generics will be considered.
OR you may have a medical information or pharmacoviligance background, if so, please give us a call asap.
Capable of negotiating with the TGA and other regulatory bodies as required.
Experience in maintaining current prescription medicine marketing authorisations.
Experience in generating Cat 1 & Cat 3 applications for prescription medicines.

Interested? Please 'apply now' quoting reference number 3029 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.
3029

Regulatory Affairs Associate

Pettit Pharma & Device Search North Shore NSW 2444

Pettit Pharma & Device Search

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