Senior Regulatory Affairs Associate

PharmaCare Laboratories


About Us

At PharmaCare Laboratories Pty Ltd, we inspire people to be the best, healthiest and happiest they can be. A 100% Australian owned company with a global presence, we are home to some of Australia’s most well-known and trusted brands, including Nature’s Way, FatBlaster, Bioglan, Brut, Skin Doctor’s, Redwin, Promensil, Wart Off, Ease-A-Cold and Sambucol. We operate and sell our brands throughout pharmacy and grocery channels within Australia and overseas.

As part of Regulatory Affairs team, this role is primarily responsible for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Australia.

Some of your key areas of responsibility include:

  • Implementing agreed regulatory strategies efficiently and in line with business needs
  • Provide regulatory support and recommendations for the assessment and market access of new products, and/or existing product development (e.g. regulatory classifications)
  • Preparation, submission and tracking of regulatory applications for a defined product portfolio of listed complementary medicines, registered medicines, medical devices, foods, cosmetics, and other FMCG products
  • Review and maintain documentation in dossier compliant to regulatory requirements
  • Identify deficiencies in product dossiers (involving problem solving and collaboration) to resolve any identified deficiencies in a solutions-oriented manner
  • Liaise with external agencies, suppliers or others to ensure compliant product dossiers and facilitate evaluation
  • Maintain adequate records and documentation of all regulatory and scientific affairs matters, including documenting and following change control procedures
  • Ensure compliance of labelling and packaging to appropriate regulations and legislation
  • Responsibility for the maintenance of databases related to regulatory activities (eg. data entry, filing of regulatory correspondence, artwork (pack) management)
  • Ensure compliance with all systems and processes
  • Working closely with local brand teams, Scientific Affairs, Quality Assurance and Technical Services to manage responses to correspondence received from the Australian regulatory authorities (e.g. TGA, FSANZ, etc) within an agreed priority and timeframe.
  • Contribute and assist in responding to post-market product assessments and audits from government agencies and regulators
  • Keep up-to-date with government legislation as it relates to regulatory affairs
  • Provide support for submissions to government regulatory consultations and reforms. 
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Skills and experience we’re looking for: 

  • Self driven, results oriented with a positive outlook and a clear focus on high quality outcomes
  • Able to work with minimal supervision with exceptional planning skills prioritising work requirements to meet deadlines in fast-paced marketing environment whilst maintaining a strong attention to detail
  • Strong analytical and problem solving skills, excellent attention to detail and a commitment for compliance processes
  • Good written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders
  • Experience and subject matter expertise in regulatory affairs (preferably in OTC registered medicines, Listed medicines, food, cosmetic, medical device and/or other related products)
  • A science-based degree or post graduate qualification.

In return, we offer:

You the opportunity to work for a growing company that operate several exciting health and skincare products, a company that has a positive company culture, and finally an attractive remuneration package. We also provide an in-house Barista, gym and fitness trainers.

 

  • Seniority level


    Mid-Senior level

  • Employment type


    Full-time

  • Job function


    Quality Assurance, Legal, and Science

  • Industries


    Consumer Goods


Apply

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