Work with global partners and highly innovative products
12 month contract, full time role, based in Kew
Specialised Therapeutics (ST) is an independent international biopharmaceutical company providing new specialist medicines and technologies to patients in Australia, New Zealand and Southeast Asia. We do this by partnering with global pharmaceutical companies, championing their products from pre-registration to full commercialisation in key regions. At ST, our primary objective is to enable people with unmet medical needs to access breakthrough, innovative therapies.
ST has carefully cultivated a work environment in which our employees are constantly challenged to do their best and think differently. We are determinedly inquisitive, perceptive and courageous, and we nurture these qualities by employing people who share our passionate interest in making a difference in patients’ lives. We pride ourselves on our friendly, collaborative, open, dynamic and inclusive team, with a permanent focus on the why.
We are currently seeking to appoint a Regulatory Affairs Associate to focus on preparing and maintaining regulatory files on various products within Specialised Therapeutics Australia (STA) as well as any further related projects and works as required. You will be responsible for liaising with representatives of STA’s licensing partners, contractors and regulatory authorities.
Your responsibilities will include:
Preparation of regulatory dossiers for submission to Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand
Liaison with TGA and/or Medsafe in relation to submission, evaluation and finalisation of regulatory dossiers
Liaison with employer’s clients to prepare regulatory dossiers and co-ordinate the reply to TGA and/or Medsafe questions raised during the evaluation
Liaison with employer’s consultants to prepare regulatory dossiers and co-ordinate the reply to questions raised during the evaluation in SEA region
Maintenance of regulatory files following product registration
Maintenance of GMP clearance for registered products and associated internal tracker
Management of artwork preparation and internal review processes
Liaison with cross functional internal stakeholders throughout the evaluation process and product launch activities.
What we are looking for
Bachelor’s degree in a relevant field (e.g. Science, Pharmacy)
3-5 years of prior pharmaceutical regulatory experience
Experience in registration of NCE and preparation of orphan, provisional and priority designations would be advantageous.
Excellent verbal and written communication skills
Strong knowledge of TGA and Medsafe processes. Additional knowledge of Southeast Asia regulatory systems would be advantageous
Ability to operate in a complex environment with excellent organisational and time management skills. Independent in daily activities, with management oversight
A self-motivated individual.
What we offer you
This is an exciting opportunity to join a company with a growing product pipeline offering employees’ a culture of support, encouragement, passion and recognition. We seek those who can bring a wealth of life experience and inspired ideas to our table. In return, we provide an inclusive and flexible workplace environment that nurtures enduring professional relationships. We provide wholesome remuneration packages with above average benefits including additional leave, private health insurance, additional superannuation, well-being grant and your birthday off!
If you are forward-thinking, dynamic in your outlook, and attracted to a challenge which is demanding and rewarding – this is your next step. If you believe you have the appropriate experience, energy and business acumen for this position, please submit your resume and covering letter to Jessica Fine at email@example.com
ST is an equal opportunity workplace. This role is only open to candidates that have full eligibility to live and work in Australia.