Regulatory Affairs

The Regulatory Affairs and Quality Team is responsible for the registration and maintenance of all Amneal product. It ensures that all products are compliant with TGA requirements before being released to market. Medical queries, product complaints regarding quality and any product safety issues, including adverse events associated with their use, are handled by Regulatory Affairs personnel.

Kristen Pearce – Regulatory Affairs & Quality Manager

Kristen has a PhD from Monash University, majoring in pharmacology and biochemistry, and brings over 15 years of Regulatory Affairs experience to Amneal. Her specialty is the registration of generics. Kristen started her career at Alphapharm and Arrow before stepping into management at Actavis. She then joined Generic Partners, overseeing the Australian team and submitting product dossiers to numerous health authorities around the world.

Kristen’s management style is to empower her team with knowledge and confidence, and to work cross-functionally across the whole business. Kristen has a strong commercial focus and views the role of the Regulatory Affairs and Quality team as facilitating the effort of Sales and Marketing. She strongly believes that everyone at Amneal shares a common goal–to get product into the market and sold! Kristen has a partner who is also in the industry. She loves travelling, an evening out with good wine, or an evening in with a good book.

Phone: (03) 8849 1205

Cathy Wadelton – Senior Regulatory Affairs Associate

Cathy holds a Bachelor of Applied Science (biological sciences) and a Diploma of Education.

For the first fifteen years of her career, Cathy focused on research & development at various biotechnology (biosynthetic vascular grafts), industrial chemistry (shoe- and car-care product development) and biopharmaceutical (CSL plasma products) companies.

During her time at CSL, Cathy was tasked to set up a group within R&D, specialising in method development, validation and quality systems (GLP). Here she authored several characterisation reports for the regulatory group’s registration dossiers, which provided a perfect segue into regulatory affairs-first at a medical devices company and then on to pharmaceuticals at Sigma/Aspen, then Ascent/Actavis and, now, Amneal.

Cathy brings 14 years of regulatory experience in biopharmaceuticals, prescription (branded and generic), OTC and devices. The scientist in her still gets to experiment, though, these days, it’s in the kitchen with new recipes (many of which make their way to work). You can also find Cathy on a bike (on the way to a good coffee), playing the guitar or cuddling her cat.

Phone: (03) 8849 1216

Michelle Lingham – Senior Regulatory Affairs Associate

Michelle completed a Bachelor of Pharmacy at the Victorian College of Pharmacy (Monash University). She undertook her pharmacy trainee year at the Royal Melbourne Hospital, where she continued to work as a hospital pharmacist for four years before heading to London. There she worked as a locum hospital pharmacist before moving into the pharmaceutical industry as a Medical Information Pharmacist (GSK).

On returning to Australia, Michelle continued to work another four years as a Medical Information Pharmacist and Manager for Faulding Pharmaceuticals/Mayne Pharma. Her primary focus during this time was supporting health care professionals by providing high quality information about medicines. Between the arrivals of her children, she transferred to a Regulatory Affairs role at Mayne Pharma, then later worked as a Medical and Regulatory Affairs consultant before accepting a Senior Regulatory Affairs position at Hospira Pty Ltd where she was responsible for regulatory submissions for Australia and New Zealand.

Michelle is now excited to have joined the regulatory team at Amneal Pharma and looks forward to utilising her skills and experience to contribute to the growth of the company in Australia.

Phone: (03) 8849 1214