Vacant job

Are you a Regulatory Affairs specialist with experience in pharmaceuticals, looking to work closely with both authorities and operations? At Pharmaxim, you will take on broad regulatory responsibility, with veterinary medicines at the core, while also having the opportunity to work with cosmetics, chemicals, and biocides in collaboration with the marketing department. This role is ideal for someone who thrives on structure, dialogue, and driving issues to completion. Are you the one we are looking for?

About the Role

This is a direct recruitment position, meaning the recruitment process is handled through Bravura, and you will be employed directly by Pharmaxim.

About the Company

Pharmaxim markets veterinary medicines and products within both Animal Health and Human Health in the Nordic region. The company has a broad and well-known brand portfolio, including examples such as Plegicil®, Banminth®, Helosan®, Salubrin®, Virkon®, and Gripen.

Pharmaxim has 21 employees and generates a turnover of just under 200 MSEK. The operations are characterized by strong team spirit, short decision-making paths, high competence, and a clear commitment to quality, safety, and regulatory compliance. The product portfolio is broad, resulting in a surprisingly large and varied regulatory workload.

You will be part of a QA/RA/PV team consisting of three experienced colleagues who support each other daily and collaborate closely, even though you will hold the internal expert role in the RA area.

What Pharmaxim Offers

• A broad and developmental role
• Opportunities for some remote work and flexible working hours
• Work with well-known and strong brands
• An inclusive and team-oriented workplace with high job satisfaction
• Health-oriented benefits

Key Responsibilities

In this role, you hold overall regulatory responsibility for Pharmaxim's products, with a focus on veterinary medicines. You will work with products where Pharmaxim is the Marketing Authorization Holder (MAH) as well as agency products.

A central task is to work on and complete regulatory documentation (dossiers) for veterinary medicines, in close dialogue with authorities and external experts. This includes handling updates according to new requirements (e.g., QRD9), managing variations, and working with product information and artwork. Concurrently, you are responsible for regulatory compliance for Pharmaxim's other products, primarily cosmetics such as Helosan, but also other categories like chemicals and biocides.

• Regulatory responsibility for veterinary medicines where Pharmaxim is MAH or agent
• Processing and updating of dossiers, variations, and product information
• Ensuring that artwork, labeling, and product information meet regulatory requirements
• Regulatory responsibility for cosmetic products, including PIF, CPNP, complaints, and adverse reactions
• Supporting operations with regulatory questions related to marketing and product changes

Education, Experience, and Personal Qualities

Requirements

• Academic degree in fields such as pharmacy, biomedicine, chemistry, biology, or equivalent
• Several years of experience in QA or RA roles within regulated industries
• Experience in Regulatory Affairs for pharmaceuticals within the EU
• Excellent ability to handle regulatory documentation and authority dialogues
• Fluent in Swedish and English, both written and spoken

Preferred Qualifications

• Experience with cosmetics, biocides, or chemical products
• Experience with artwork, labeling, and mock-ups

You work in a structured and methodical manner and feel confident handling complex regulatory issues. You are comfortable communicating with authorities and external partners and have an eye for detail without losing sight of the big picture. You thrive in an environment where independent work, breadth, change, and collaboration are natural parts of daily life, and where lack of pretension and responsibility go hand in hand.

We look forward to receiving your application!

Additional Information

Start Date: As agreed
Location: Landskrona
Salary: As agreed

We use a competency-based methodology in all recruitment processes to ensure unbiased selection. We also conduct ongoing selection, meaning we remove the ad once enough candidates have applied. If you are considered for the position, we will contact you for a first phone interview. Regardless of whether you proceed in the process or not, you will receive feedback on your application.

Do you have questions? Feel free to reach out!

📧 [email protected]

📞 010-171 47 10

We recommend submitting your application immediately as we conduct ongoing selection.

We look forward to receiving your application!

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