Regulatory Site Lead

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** Regulatory Site Lead**
* **
* Location:

Virginia, Brisbane***
* *** Exposure to leadership***
* *** Full-time, permanent role
*** Opella is the self-care challenger with the purest and
** third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally**.Our mission: to bring health in people’s hands by
** making self-care as simple as it should be
** for over half a billion consumers worldwide.

At the core of this mission is our
** 100+ loved brands**, our
** 11,000-strong global team, our 13 best-in-class manufacturing sites
** and four specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including
** Natures Own, Cenovis, Ostelin, Telfast, Buscopan and Bisolvon.
**** B Corp certified in multiple markets**, we are active players in the journey towards healthier people and planet.

Find out more about our mission to bring health in your hands at
** About the job
** The
** Regulatory Site Lead
** reports directly to the
* Site Quality Head
* and is responsible for the Regulatory activities required to support the manufacture and distribution of all the products manufactured on site.  Products manufactured on site are registered and distributed in a number of markets both in Australia and within Asia, therefore knowledge of these markets is a must.
This is a highly visible role within the region and involves cross-functional collaboration with various functions such as Commercial, Manufacturing, Science, Brand and Innovation.
*
* Main Responsibilities:

*** Preparing registration dossiers of drugs, food and health supplements for new products, products with licenses due to expire, products with changes
* Involvement with the Development Center in checking registration regulation with relevant markets for new product projects.
* Joining with Development Center in reviewing dossiers of new products before submission
* Evaluate change controls for regulatory impact
* Gap analysis between product registration dossiers and actual site practices of production and Quality Control activities (dossiers vs. site SOPs).  Development of action plans to close gaps (if any) with supports from the department head to assure the compliance
* Defining new requirements in terms of technical dossiers for products in case of a new registration regulation, or of a new version of applicable Pharmacopoeia.  Then set up a strategy of registration and follow up the implementation
* Involvement and contribution in product transfers, technical transfer projects
* Product label verification: check the contents of the product labels complied to the approved registration ones
* Provide product specifications to the Quality Control team when requested
* Product barcode registration for Australian barcodes and foreign barcodes
* Import license registration for raw materials, packaging materials, reference standards
* Update data on Sanofi Global systems as requested
* Participate and support HSE activities.
** About you
***
* Qualifications:

*** University degree in Pharmacy, Science related discipline or Regulatory Science  
** Experience**:
* Preferably 6 + years experience site regulatory management within Consumer Healthcare or Over The Counter (OTC) preferred
* Exposure to Dossier submission process and registration of products in Asia Pacific region (ASEA) is a must
* In depth knowledge of TGA and Asian regulations for drug, food and health supplements.  Also have a good knowledge and understanding of GMP, GLP and GDP guidelines and regulations.
*
* Skills:

*** Strong organisation, planning and critical thinking skills. Has the ability to set and action priorities to meet objectives.
* Highly collaborative and is able to influence and achieve results in a team environment across multiple functions and stakeholders
** Languages**:
* English, and multilingual highly desirable for ASEA market

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
** We Are Challengers.
** We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
** All In Together:
** We keep each other honest and have each other's backs.
** Courageous:
** We break boundaries and take thoughtful risks with creativity.
** Outcome-Obsessed:
** We are personally accountable, driving sustainable impact and results with integrity.
** Radically Simple:
** We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.#LI-Hybrid
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