Senior Specialist, RA Labelling

ORIFARM A/S; Odense; On-site; DKK 650,000 - 900,000; Full time

Benefits offered by this job

Collaborative international working environment

Access to a canteen with healthy meals

Regular social events

Job summary

ORIFARM A/S in Odense is looking for a Senior Specialist in Regulatory Affairs Labelling to shape regulatory excellence across borders. This role requires preparing high-quality product information and collaborating with diverse stakeholders. You will thrive in a dynamic environment and be part of a supportive team, contributing to the success of our innovative projects.

The ideal candidate has over 5 years of experience in regulatory affairs, focusing on labelling, and is fluent in English as well as a Nordic language. Join us to make a real impact!

Qualifications

• 5+ years of experience in Regulatory Affairs with focus on labelling.
• Fluent in English and a Nordic language (preferably Finnish).
• Strong analytical, coordination, and problem-solving skills.

Responsibilities

• Create and maintain product information across multiple countries.
• Review, proofread, and approve artwork and mock-ups.
• Monitor and implement European regulatory legislation.

Skills

Regulatory Affairs

Labelling

Analytical skills

Problem-solving

Education

Degree in Pharmacy or Life Sciences

Job description

Category: Regulatory Affairs
Country/Region: DK
Location: Odense S, DK, 5260

Ready to shape regulatory excellence across borders?
At Orifarm, we are looking for a passionate Senior Specialist in Regulatory Affairs Labelling who wants to make a real impact in a dynamic, international environment. If you thrive on complexity, have a keen eye for detail, and enjoy working across markets and cultures, this could be your next step.

You’ll join a collaborative and experienced labelling team where your expertise will directly influence product information across multiple European markets—and where your ideas, ownership, and growth truly matter.

Your key responsibilities

In this role, you will play a central part in ensuring high-quality, compliant product information.

• Creating and maintaining product information (SmPCs, labelling, and patient leaflets) across multiple countries
• Reviewing, proofreading, and approving artwork and mock-ups
• Performing SmPC comparisons and ensuring consistency
• Supporting Risk Management Plan (RMP) updates
• Updating educational materials
• Monitoring and implementing European regulatory legislation
• Collaborating with internal stakeholders and external authorities

Who are you?

You are a proactive and detail-oriented regulatory professional who enjoys working both independently and as part of a team. You communicate confidently across functions and cultures and are not afraid to take ownership.

Qualifications

We expect you to:

• Hold a degree in Pharmacy, Life Sciences, or similar
• Bring 5+ years of experience in Regulatory Affairs, with a strong focus on labelling and variations
• Be fluent in English (written and spoken)
• Have native-level proficiency in a Nordic language (preferably Finnish); additional languages are an advantage
• Possess strong analytical, coordination, and problem-solving skills
• Work with a high level of accuracy and a GxP and business mindset
• Thrive in a dynamic, fast-paced and evolving environment

What do we offer

You will become part of a highly engaged labelling team of around 10 specialists, split between Denmark (Odense & Copenhagen) and Poland (Warsaw). We pride ourselves on a culture that combines professionalism with openness, trust, and a good sense of humor.

We offer:

• A collaborative and international working environment
• High degree of ownership and flexibility in your role
• Opportunities for professional and personal development
• A supportive team culture with strong knowledge sharing
• Access to a canteen with healthy meals and a massage service at our Odense office
• Regular social events and gatherings to ensure employee engagement
• Participation in a bonus scheme for outstanding performance

Multilocation role

This is a multilocation position, and the role can be based in one of our key locations (FI, DK, SE, NO, or PL). Please note that compensation and benefits packages may vary depending on the country of employment and local market conditions.

Inclusion

We encourage everyone to apply. At Orifarm, we welcome people from all backgrounds, recognizing that the best outcomes come from a diverse and inclusive work environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable future. By creating such an environment, we are confident that we can achieve better results together.