AddressJob: Senior SpecialistRegulatory Affairs
Location: Sydney, Australia
(Hybrid working opportunity)
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.
Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network complement our global operations.
ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Sr. Specialist Regulatory Affairs.
Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization's (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements.
What You'll Do:
- New registration applications
- Review the dossier against Australian/NZ country specific guidelines and prepare gap analysis Report.
- Liaise with contract manufacturers and concerned regulatory authority for resolution of issues identified in the gap analysis report.
- Prepare Pre‐submission Planning Form (PPF) and supporting documentation for submission. Prepare dossier for submission.
- Obtain GMP clearance for all relevant manufacturing sites and hand over to assigned Regulatory Affairs team member for GMP for maintenance after clearance has been issued.
- Prepare and process artwork in the ADVANZ PHARMA artwork management system.
- Respond to deficiency letter/s and update relevant database with approved product registration information in line with applicable ADVANZ PHARMA SOPs/WIs
- Complete allocated post‐approval regulatory activities within stipulated timelines
- Submission related administrative work in ADVANZ PHARMA system such as Veeva, GLAMS,
RIM, and SAP.
- Pre‐launch regulatory activities
- Prepare and submit product variations required immediately after approval of registration application (Pre‐launch variation).
- Raise change control in line with applicable ADVANZ PHARMA SOPs/ Wis as necessary identify the data to support the variation and application type, and complete Regulatory impact assessment accordingly.
- Carry out the same responsibilities as mentioned in new registration applications.
- Strategy and Business Support
- Provide Senior Business Development Manager with registration strategy and requirements for products or other regulatory advice on request and Initiate enquiries with regulatory authorities regarding the above as required.
- Routine monitoring of storage room temperature conditions of all products stored at in‐house facilities.
- Monitoring changes in regulatory environment
- Maintain up‐to‐date knowledge and information on the regulatory environment for prescription and over‐the‐counter medicines in AU and NZ as relevant for the role.
- Monitor updates to regulations, guidelines and policies in AU and NZ in relation to the company's product registrations.
- Team development
- On‐going training and mentoring of more junior Regulatory team members (all aspects of RA)
- Peer‐review of applications prior to submission to authorities as required.
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients' lives.
For this role, you will also have the following:
Qualifications:
- Formal Training in Regulatory Affairs.
- Graduate in any discipline of science, preferably life science / Pharmacy or Post-Graduate in Regulatory Affairs.
Knowledge, Skills & Experience:
- Significant experience in Regulatory Affairs, including expertise in Prescription medicines in a highly regulated market.
- A sound understanding of regulations, guidelines and policies relating to prescription medicines.
- Previous experience with TGA and Medsafe
- Experience in Regulatory Affairs for OTC and complementary medicines and devices
- Experience in Quality Assurance activities.
- Experience in electronic submissions.
- Should be a natural with Relationship building, Mentoring, managing change and possess decent Commercial acumen.
- Good Project Management and Communication skills.
- Pleasant personality with collaborative approach, interpersonal skills, high on team spirit
- Demonstrate sense of drive and urgency through work.
- Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented).
- A positive and 'can-do' approach, biased towards finding solutions and embracing change.
- Inspired by our values of entrepreneurship, speed and integrity.
- Learning agility and 'scalability', with a desire to continuously improve and develop as ADVANZ grows.
- Work collaboratively across all business functions with an open, honest, and respectful cooperation.
- Ability to have fun and thrive in a growing, unique, and inclusive work environment.
Why ADVANZ PHARMA?
The success of any company is driven by its people, and we are no different.
At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.
Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.
As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you'll be empowered to own your work, explore new possibilities, and make things happen.
But there's more to you - and us - than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles - we have an active ADVANZ PHARMA Women's Network; almost 40% of our managers are women.
We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.
We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.
To join us on our exciting journey, Apply now! *
- Please include a CV and Cover letter.
