Senior Regulatory Affairs Associate, Labelling Operations
CSL
Australia, Victoria, Parkville
26d ago

Job Description

Seqirus is the global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis.

Now the second largest influenza vaccine company in the world, and with complementary vaccine, anti-venom and diagnostic products, Seqirus has extensive research and production expertise and manufacturing plants in the US, UK and Australia.

With a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries, Seqirus has ambitious growth targets of a $1bn turnover by 2020.

The future is exciting and full of potential.

Located in Parkville (Australia), a full-time, 12 month maternity leave replacement role within the Global Strategic Labelling team has become available.

As part of this close knit expert team you will :

  • Interface with key stakeholders across the business to ensure timely development, approval and maintenance of printed artwork for Seqirus globally marketed products (in compliance with GMP);
  • Maintain awareness of and expertise in regulatory guidelines relevant to role;
  • Provide regulatory support for the management of labelling systems, including maintenance and training;
  • Participate in process development and process improvements, and development of training modules and compliance metrics associated with labelling operations;
  • Provide regulatory maintenance and development of data management / tracking tools for labelling to ensure compliance.
  • Tertiary qualified in biological science, allied medical discipline or pharmacy, with complementary experience in a pharmaceutical / biotechnology industry; you ideally possess :

  • A minimum of 3-5 year’s experience in the pharmaceutical industry, with technical knowledge of labelling , systems and process development.
  • Knowledge of global labelling legislation and guidelines for medicines would be advantageous);.

  • Process and Systems experience;
  • Demonstrable experience of effective delivery of objectives in a complex matrix environment;
  • Highly developed organisational skills including planning and time management;
  • Flexibility and the ability to work effectively with a range of different Global functional areas;
  • Strong problem solving and analytical skills supported by excellent attention to detail.
  • If you are excited by the possibilities of shaping public health, then please send an application addressing the selection criteria above and including a current CV and covering letter.

    Applications will close on Friday 6th July 2018

    Job R-065349

    CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process.

    Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies.

    Important notice to Employment businesses / Agencies

    Seqirus does not accept unsolicited referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact Seqirus' Talent Acquisition to obtain prior written authorization before referring any candidates to Seqirus.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and Seqirus.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of Seqirus.

    Seqirus shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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