Senior Regulatory Affairs Associate

Regulatory Affairs/Clinical Affairs Belrose, NSW Balcatta, WA


Description

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

By joining our Regulatory Affairs Department, you will be working on maintaining and expanding our exciting range of consumer and specialist clinical brands such as Nicotinell, Herron, Tiger Balm, Surgi Prep and Oripro. Reporting to the Regulatory Affairs Manager, you will support our business growth by playing a critical role in cross-functional new product development teams to establish product requirements, working with marketing to create products with unique attributes and indications to support product claims. You will have ownership of regulatory responsibilities for product registration with support from the Regulatory Affairs Manager and you cross-functional team members.

The role is based in Sydney or Perth, with the ability to work from home. Other locations will be also be considered.

Duties

  • Responsible for new product submissions to TGA and Medsafe including working with cross-functional project teams to establish and execute regulatory strategies and schedules.
  • Work closely with our Marketing and Sales teams providing recommendations for marketing initiatives, product claims and support sales campaigns.
  • Perform product regulatory life cycle activities efficiently to ensure compliance.
  • Manage interactions and negotiate with TGA and Medsafe to achieve business goals.
Skills & Experience
  • Educated to a degree level in pharmaceutical, medical or science related subjects with a minimum 5 years pharmaceutical industry experience in regulatory affairs.
  • Extensive experience working across marketing, advertising, and branding within the consumer health care space.
  • Have a positive can-do attitude; be willing to challenge the status quo with a strong work ethic and demonstrated resilience and commitment to goals.
  • Good attention to detail along with exceptional skills in oral and written communication including building persuasive arguments.
  • Ability to critically appraise data with high attention to detail.
  • Excellent organisation and planning skills with the ability to work autonomously.
  • Computer literacy with MS Word and Excel commemorate with the role responsibilities. Proficiency with project planning and eCTD software would be advantageous.

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.