29 days agoRoche

Regulatory Affairs Associate- 14 Months Fixed Term Contract

  • Sydney (Sydney)
  • IT development

Job description



·  Job facts

At Roche, we believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work every single day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Doing now what patients need next.

·  Opportunity to develop and implement regulatory strategy for prescription medicines
·  Support for a rich portfolio of products
·  Located in the Sydney CBD with a flexible work environment

We now have an opportunity for two regulatory professionals to join our team in developing innovative regulatory strategies for our cutting edge portfolio of new products that will make a meaningful difference to patient's lives, across a diverse range of therapeutic areas , You will also be responsible for managing regulatory activities and ensuring ongoing compliance and maintenance of existing registrations for Australia and New Zealand. You will be solution oriented and enjoy working as and proactively contributing to a vibrant team.

Reporting directly to the Regulatory Affairs Manager,you will have responsibility for regulatory activities associated with a range of products and responsibilities include:

·  Identifying key issues and developing strategies for successful regulatory activities for products in Australia and New Zealand
·  Submit final regulatory submissions to health authorities in Australia and New Zealand and work closely with these health authorities to deliver timely approval and the broadest use of products for the benefit of patients.
·  Undertake issues management when necessary
·  Stay abreast of internal and external developments, trends and other dynamics as these potentially influence Roche's pipeline, marketed products and other business interests
·  Proactively interface with and effectively collaborate with cross functional stakeholders with regard to regulatory strategies and requirements

Where passion meets purpose

Ready to take on some of life's toughest diseases?

At Roche, the world's largest biotech company you can, with the industry's strongest pipeline in specialised medicines. Take pride in knowing you can make a difference to millions of patients worldwide developing treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases and respiratory disease.

With our commitment to research, we're pioneering breakthrough medicines and leading the exciting frontier of personalised healthcare.

Anything's possible, in a friendly, collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. Find balance in our market-leading commitment to flexibility. Enjoy access to our dynamic headquarters, located in vibrant Barangaroo Sydney.

Be energised, growing your career alongside 350+ local and 94,000 global colleagues; tenaciously working together as one team. Guided by our values of courage, integrity and passion we look to fulfil our purpose – doing now what patients need next and in doing so improve patients' lived now and for tomorrow.

What will be your legacy?

All facets of diversity are important to us and we endeavour to create an environment where everyone, regardless of factors such as gender, age, race, ethnicity, sexual orientation, gender identification or religion can contribute and realise their potential. As part of celebrating diversity, we welcome applications from all people who are passionate about doing now what patients need next.

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

Applications close on 27th October 2019.

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in house Talent Acquisition team.

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.