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Regulatory Affairs Manager

1 month ago

Docklands, Australia Australian Pharmaceutical Industries Full time

Wesfarmers Health was formed in March 2022, with the acquisition of Australian Pharmaceutical Industries (API). Our supporting portfolio of brands includes Priceline, Priceline Pharmacy, Soul Pattinson Chemist, Clear Skincare Clinics, InstantScripts and SILK Laser Clinics.

**About us:
Since our humble beginnings in 1910, we’ve grown from a small co-operative of three pharmacies to a national organisation and one of Australia’s leading health, beauty, and wellness companies.

The Wesfarmers Health includes 73 company-owned Priceline stores, 396 Priceline pharmacy franchise stores and 89 Clear Skincare clinics and is also a wholesale distributor of pharmaceutical goods. In 2023, the Health division expanded its digital and medical aesthetics offering with the acquisitions of telehealth provider InstantScripts, as well as the SILK Group, who operates a network of around 140 wholly-owned, joint venture and franchised clinics. The division employs more than 3600 team members.

**What you’ll do:
As the Regulatory Affairs Manager, within the Private Label Team, your role will be pivotal in upholding top-tier regulatory compliance standards across various product categories such as OTC medicinal items, listed medicines, medical devices, cosmetics, and hard goods. Your focus on regulatory adherence and pharmacovigilance will extend to overseeing both domestically sourced products in Australia and those sourced from international suppliers.

Your leadership will be instrumental in guiding a Quality Associate to ensure seamless quality processes within the Private Label department. Understanding the pivotal role of Regulatory and Quality functions in the success of Wesfarmers Health Private Label, you will actively contribute to the business's growth trajectory as a key member of the team.

**What you’ll bring:
- 8 years + of experience in regulatory affairs (with 3 years min in a leadership role) across either pharmaceutical, OTC, health supplements, beauty, and personal care industries
- Hands on experience in commercial regulatory affairs and pharmacovigilance
- In-depth understanding of Australian and NZ regulatory standards for OTC medicines, listed medicines, medical devices, cosmetics, and hard goods.
- Proficient in working with the Therapeutic Goods Administration (TGA), including product listing, registration, and ensuring product label compliance.
- Skilled in reviewing marketing materials to ensure adherence to advertising regulations.
- Familiarity with regulatory submission processes.
- Proven track record in team management, fostering a collaborative and results-oriented work environment, coupled with strong commercial awareness, particularly advantageous in retail business settings. Bachelor's degree in a scientific field, Pharmaceutical Sciences, or a related discipline.

Join us in shaping a supportive and thriving work environment where every team member plays a crucial role in our collective success.

**What you’ll get:
- Ongoing professional development and career opportunities across the Wesfarmers Health Division and the broader Wesfarmers Group
- Access to employee benefits across Wesfarmers including team member discounts at Bunnings, Kmart, Target, Officeworks, OnePass, Priceline and Clear Skincare Clinics.
- ‘We Love Your Work’ recognition program. Team members can recognise their peers, team or other business units, with winners taking part in our annual awards.
- Access to our Employee Assistance Program (EAP) - available to all team members and their immediate family members, 24/7, 365 days a year.
- Beautiful outdoor terrace for work and recreation.
- Food, coffee and health & wellbeing facilities onsite including a landlord operated gym Dedicated end of trip facilities (cycle racks, showers, lockers).

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