Senior Regulatory Affairs Associate

Regulatory Affairs/Clinical Affairs Belrose, NSW Balcatta, WA


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

About the role

An exciting opportunity has arisen with a leading global pharmaceutical company with a diverse portfolio. Reporting to the Regulatory Affairs Manager, you will support our business growth by playing a critical role in creation and co-ordination of product registration applications. While the role is intended to be Sydney or Perth based, other locations will be considered, with the ability to work from home.

Duties

  • Manage, execute and submit high quality generic products dossiers to the TGA and Medsafe.
  • Develop timelines and regulatory strategies for new products; assess Quality and Clinical sections of potential new product dossiers.
  • Conduct initial change control assessment to determine the requirements for product change applications to ensure continual regulatory compliance in Australia and New Zealand.
  • Maintenance of product life cycle regulatory activities including artwork, PI/CMI and GMP clearances.
  • Manage interactions and negotiate with TGA and Medsafe to achieve business goals.
  • Assist in the preparation and maintenance of Standard Operating Procedures for regulatory associated activities, as applicable.
Skills & Experience
  • Educated to a BSc level with pharmaceutical, medical or science related subjects.
  • Minimum 5 years pharmaceutical industry experience in regulatory affairs, in generic OTC products.
  • To be successful in this role you will have a positive can-do attitude, a good attention to detail along with exceptional skills in verbal and written communication including building persuasive rationales.
  • Advanced computer literacy (word processing, spreadsheets, databases and project planning software) and eCTD software.
  • Ability to critically appraise data with high attention to detail.
  • Advanced computer literacy (word processing, spreadsheets, databases and project planning software) and eCTD software.
  • Excellent organisation and planning with the ability to work autonomously.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.