Senior Manager, Regulatory Affairs - Specialised Therapeutics

• by Specialised Therapeutics
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About The Role

The Senior Manager, Regulatory Affairs plays a key role in leading, preparing and maintaining regulatory files on various products within ST as well as any related projects. Reporting to the Head of Regulatory Affairs, your key responsibilities will include:

• Communicating regularly with the Head of Regulatory Affairs and other ST team members in cross functional teams to optimise company goals
• Completing all reports, submissions and plans of action in a timely manner
• Effectively communicating appropriate technical, therapeutic, disease state and product information to ST team members
• Independently preparing and submitting regulatory dossiers for submission to the relevant regulatory authorities in Australia and New Zealand
• Liaising with relevant regulatory authorities in Australia and New Zealand in relation to the submission, evaluation and finalisation of regulatory dossiers
• Supporting the preparation and submission of regulatory dossiers for submission to the relevant regulatory authorities in Southeast Asia
• Liaising with ST’s partners to prepare regulatory dossiers and coordinate the reply to TGA and/or Medsafe questions raised during the evaluation
• Maintenance of regulatory files following product registration
• Maintenance of GMP clearance for registered products
• Liaising with Therapeutic Leads throughout the evaluation process and product launch activities

 

About You

You are a self-motivated, experienced and detail oriented regulatory professional who thrives in complex environments where priorities evolve quickly. You will have:

• A tertiary qualification in a relevant scientific discipline
• Extensive experience of relevant pharmaceutical regulatory affairs
• Leadership skills in project managing complex regulatory submissions with multiple stakeholders in Australia and internationally
• Strong knowledge of the TGA, international GxP regulations, guidelines, and emerging regulatory processes. Additional knowledge of New Zealand and/or Southeast Asia regulatory systems would be advantageous
• Proven ability to prioritise and manage multiple high-stakes projects simultaneously in a fast-paced environment
• Excellent verbal and written communication skills
• Strong integrity and work ethic
• Previous experience in a consulting environment would be advantageous

 

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, a well-being grant and your birthday off!

 

About Us

Specialised Therapeutics (ST) is the region’s largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. We partner with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. Our mission is to provide specialty therapies where there is an unmet need. Our broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas.

 

Culture

ST has carefully cultivated a work environment in which our employees are constantly challenged to do their best and think differently. Our company is determinedly inquisitive, perceptive and courageous, and nurtures 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.

 

Apply now!

This is an exciting opportunity for a talented individual who would like to move their career forward with a collaborative team and an innovative organisation. If you believe you have the appropriate experience, energy and business acumen for this position, please submit your resume and cover letter to Jessica Fine at jfine@stbiopharma.com

ST is an equal opportunity workplace. 

This role is only open to candidates that have full eligibility to live and work in Australia.