Regulatory Affairs Officer

Orion Corporation; Arques; Sur place; EUR 48 000 - 72 000; Plein temps

Résumé du poste

Orion Pharma in France is seeking a motivated Regulatory Affairs Officer for Veterinary Medicines to maintain marketing authorizations across regions, with focus on the EU, and potential to specialize as a CMC writer. You'll work with R&D, QA and Manufacturing to ensure compliance, prepare variations, update the quality part of the dossier, respond to authorities, and verify artwork for the French market.

This role offers onboarding and the chance to grow within Animal Health, a global division

Qualifications

• Degree in chemistry, life sciences, or related field.
• Experience with CMC (module 3 or part 2) dossier writing is required.
• First experience in regulatory affairs for human or veterinary medicines would be beneficial.
• Fluency in English and French.
• Strong team player with planning and accuracy skills.
• Ability to collaborate with people from various countries and cultures.
• You hold a valid work permit for France.

Responsabilités

• Prepare regulatory submissions, mainly for variations for an upcoming manufacturing line transfer.
• Write and update the quality part of the regulatory dossier, i.e. p2
• Respond to questions from the regulatory authorities.
• Ensure regulatory compliance of veterinary medicine product information and quality dossier.
• Collaborate effectively with internal teams (Regulatory Affairs, Quality Assurance, R&D)
• Submit and monitor change requests following approval of variations or other regulatory activities.
• Verify artwork and promotional materials for the French market.

Connaissances

Regulatory submissions

CMC writing

Cross-functional collaboration

English & French fluency

Attention to detail

Formation

Degree in chemistry or life sciences

Outils

CMC dossier writing

Description du poste

We are looking for a motivated and detail-oriented Regulatory Affairs Officer - Veterinary Medicines to join our team. In this role you will be responsible for the maintenance of marketing authoriztations (MA) in various regions.Your focus will be on the EU region, with opportunities to expand your responsibilities and to specialize as CMC writer over time. You will work closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure our products meet all legal and safety requirements. The role will carry out activities to ensure regulatory compliance for veterinary medicinal products.

Your responsibilities

• Prepare regulatory submissions, mainly for variations for an upcoming manufacturing line transfer.
• Write and update the quality part of the regulatory dossier, i.e. p2
• Respond to questions from the regulatory authorities.
• Ensure regulatory complianceof veterinary medicine product information and quality dossier.
• Collaborate effectively with internal teams (Regulatory Affairs, Quality Assurance, R&D)
• Submit and monitor change requests following approval of variations or other regulatory activities.
• Verify artwork and promotional materials for the French market.
  

What we offer

• An onboarding programme to get you quickly up to speed.
• An opportunity to work in a dynamic, collaborative environment with multiple internal and external stakeholders.
• Competitive salary, benefits, and growth opportunities within a leading company in the industry.

Orion is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

To succeed in this role, you bring the following background and skills:

• A degree in chemistry, life sciences, or a related field (e.g., laboratory techniques, biology, biomedical sciences).
• Experience with CMC (module 3 or part 2) dossier writing is required.
• First experience in regulatory affairs for human or veterinary medicines would be beneficial.
• Fluency in English& French
• Strong team player with excellent planning and accuracy skills.
• Ability to collaborate with people from various countries and cultures.
• You hold a valid work permit for France .
  

About Animal Health

The mission of Animal Health is to improve the quality of life for animals. Animal Health manufactures and markets in-house developed medicines as well as numerous generic drugs for both companion and livestock animals. We are committed to making daily life healthier and less stressful for both animals and the people who care for them.

We produce and distribute over 300 veterinary medicines and are present in over 100 markets around the world servicing the needs of our customers in both the companion animal and livestock sectors. Our manufacturing and supply chain operations are located in France and Belgium.

Animal health is a diverse team of over 300 professionals, based in 13 countries across Europe. We operate as one unified team, bringing together expertise from various departments including Sales, Marketing, Operations and Supply Chain, R&D, Quality Management, HR, Finance, and IT. The Animal Health culture that we foster is one of collaboration, inclusivity, and innovation, where everyone feels empowered to contribute and challenge the status quo. We aim to prioritize the customer and work together toward shared goals.

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.