RA & QA Manager to Niconovum

Regulatory Affairs & Quality Assurance Manager to Niconovum

Do you thrive on challenges and want to be a key player in our growth journey? Would you like to be part of the entire product cycle, from registration to marketing and launch? Do you have experience with pharmaceuticals but is looking to put this to use in a smaller, more flexible, and agile workplace, which will allow you to drive your own initiatives, build upon your strengths, and explore your limits?

Look no further - Niconovum AB is looking for a new Regulatory & QA Manager.

The company
Niconovum AB is a medical company that markets innovative nicotine replacement therapy (NRT) products under the Zonnic brand. Our products are sold in four markets: Sweden, Norway, Finland and Iceland, and our brand is third in terms of market share in each Nordic market it competes in. All products are regulated and approved pharmaceuticals.

The role
As RA & QA Manager, you will be based in our Hyllie office and report directly to the CEO. You will also interact with all internal and external stakeholders and parties – so you must have excellent communication skills and the ability to create and maintain good relationships.

Your main goal is to ensure regulatory and quality compliance for existing products, while supporting product development and geo-expansion activities in all matters related to quality and regulatory affairs. This includes product regulatory approvals, variation applications, change control, risk assessments, supplier quality management, and launch strategies – as well as management reviews, SOP´s, and inspections. You are also expected to become the company´s Responsible Person for GDP, either directly or after training.
To your support you will have colleagues and external consultants with expertise within NRT, formulation, CMC, pharmacovigilance, project management, RA and QA.

In short, your responsibilities will be to:

• Maintain and update regulatory dossiers, as needed
• Manage regulatory strategies for new product approvals, line extensions or expansion into new markets
• Manage approvals and registration of artwork
• Maintain Quality system, manuals and policies
• Ensure documentation of relevant activities and processes
• Ensure the safety and quality of all products throughout the production and distribution processes
• Handle consumer and customer questions and complaints
• Act as the local pharmacovigilance manager and support to QPPV
• Coordinate all internal and external inspections and audits
• Evaluate new GxP partners and quality agreements
• Ensure wholesale distributor obligations are being met
• Support to the manufacturer´s QP
• Manage the department budget

To succeed in this role, we think you have:

• A Bachelor´s or Master´s degree in a relevant field, preferably within pharmacy
• 3+ years in Pharmaceuticals, handling regulatory issues and related documentation
• Experience with GDP/GMP/GVP
• Excellent communication skills both written and verbal
• Proficiency in both Swedish and English

But above all, we value the right personality and attitude – and this means a balance between structure and flexibility; a strategic mindset with operational hands; an analytical approach paired with a solutions-oriented mentality. As we nurture our suppleness and adaptability, we would like for you to embrace the possibility to take a holistic view while also rolling up your sleeves and dive into the practical details, to take initiatives and stand up for them, and educate others along the way.

Are you ready?

This process is in collaboration with Badenoch + Clark. For any questions regarding the position, please reach out to Senior Consultant Matilda Rodey at matilda.rodey@badenochandclark.se.
We look forward to receiving your application as soon as possible and no later than June 13th, at www.badenochandclark.se or using link below. Selection will be ongoing – so contact us today!