Regulatory Compliance Officer
NorgineAbout the role
Are you and expert in, and have a passion for Regulatory Compliance? Would you like to apply your expertise to impact Regulatory Compliance in a growing European Pharmaceutical company where patients truly matters to us? Then this role at Norgine is for you!
In this key role in our business, the Regulatory Compliance Officer will responsible to support the Italian Norgine affiliate in providing fit for purpose GxP related activities performed by our Regulatory Affairs Team.
Sound interesting? Then read on…
In this role, you will be supporting the Regulatory Affairs team in the GxP related activities and acting as QMR deputy in listed quality activities. You will also deputise as RP deputy for Norgine Italia, as per “Delegated GDP activities” Certification Team member in Norgine Italia. You also support the Business Integrity Manager in the Farmindustria Certification audit to ensure compliance with applicable Code of Practice, for the activities under their responsibility
Ultimately, at Norgine, we look for the following skills and experience in our Regulatory Compliance Officer;
- Degree in a relevant life science subject or equivalent
- Experience in the pharmaceutical industry
- An awareness of the drug development process
- Product knowledge
- Awareness, understanding and an ability to pragmatically interpret GxP and Code of Practice requirements relevant to his/her responsibilities
- Demonstrable analytical and monitoring skills
- Focus on customer needs, follows up on commitments and requests
- Ability to work successfully in a matrix organisation
- Work cooperatively within a team
- Good interpersonal skills and ability to establish effective working relationships with internal and external stakeholders at Norgine
- Ability to communicate clearly in English
- Good verbal and written communication skills ability to present effectively to groups
- Good ability with Microsoft Office (Word, Excel, PowerPoint)
If this resonates and is what you might be searching for, apply now!
A recent acquisition by Goldman-Sachs, Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 24 million patients around the world in 2021 and generated €505 million in net product sales, a growth of 10% over 2020.
Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.
In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
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