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Regulatory Affairs Associate at Nova Pharmaceuticals Australasia Pty Ltd.
Permanent
About The Company
Nova Pharmaceuticals Australasia is a dynamic Australian-based pharmaceutical company based in Sydney, focused on providing value to its customers by delivering high-quality affordable medicines. Nova markets a diverse range of therapeutic goods, and has established itself as one of the leading supplier of branded generic and private label products in Australasia. Nova’s products include a wide range of oral analgesics, antihistamines, cough and cold medicines, medical devices, complementary medicines, dermatological products and prescription medicines.
THE OPPORTUNITY
Nova is looking for a professional Regulatory Affairs Associate to join our Regulatory Affairs teamreporting into the Regulatory Affairs Senior Manager-Prescription. This Regulatory Affairs Associate supports Nova’s business growth through excellent regulatory service and outcomes within its varied portfolio of products. Nova’s Regulatory Affairs team are very capable and passionate individuals committed to getting the best outcomes for its consumers, patients, and the customers. This opportunity, will expose the successful candidate to a very diverse range of products that will provide professional satisfaction
If you are excited by and have experience in regulatory affairs, specifically with prescription medicines, and would like to be exposed to a broad range of therapy areas, this role is for you.
This role is a permanent position based full time at Nova’s head office in Bella Vista.
Responsibilities
· Perform gap analysis on prescription regulatory dossier packages and resolve deficiencies prior to submission.
· Prepare and submit Category 1 applications for prescription products in a variety of therapeutic areas in
Australia and New Zealand.
· Respond to the TGA s31 questions across the various prescription milestones in a timely manner.
· Preparation and submission of module 1 element such as: product information, consumer medicine information,
· Evaluate, compile and submit variation applications (SAR, SRR, Category 3 etc) in Australia and New Zealand for
assigned products or as advised.
· Proactively and collaboratively work with overseas affiliates and local colleagues in the management of
regulatory applications and responses to authority questions.
· Publishing of dossiers or variations into eCTD using eCTD software.
· Provide accurate and timely regulatory advice to the Nova business teams as required.
· Ensure high quality and timely outcome of various regulatory submissions and evaluations.
· Effectively participate and contribute to the regulatory project meetings.
· Keep pace with changes to regulatory and industry environment and guidelines.
Skills and Experience
· Have at least 3 - 4 years’ experience in Regulatory Affairs role working within the prescription pharmaceutical
industry in Australia.
· Have strong experience in submitting prescription Category 1 applications to the TGA.
· Have experience in end-to-end submission of Category 1 applications for prescription medicines to the TGA.
· Knowledge of Australian and New Zealand medicine regulatory requirements and processes.
· An understanding of the new product development and commercialisation processes.
· Minimum a Bachelor’s degree in pharmacy or a Life Science discipline.
· Must demonstrate strong technical expertise working with the TGA.
· Must be able to work independently with minimal supervision to meet the deadlines.
· Is a self-starter with a positive attitude, good attention to detail, and a sense of urgency.
· Excellent verbal and written communication skills.
· Can demonstrate ability to connect with internal and external stakeholders, and able to shape outcomes and
· Ability to read, understand, interpret and follow regulatory guidelines.
· Attention to detail and organised.
· Strong problem-solving skills.
· Adaptable/flexible approach to work.
Culture:
• Fast-paced, dynamic and innovative culture
• Encourages diversity and creativity
Nova is an equal opportunities employer, we are committed to diversity and inclusion within the workplace and believe that a diverse team with unique perspectives, ideas and experiences should be valued.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Pharmaceutical Manufacturing
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