International Regulatory Affairs Manager

Somvital; Zaragoza; On-site; EUR 35,000 - 60,000; Full time

Benefits offered by this job

On-site position

Career development opportunities

Autonomy and responsibility

International project involvement

Job summary

SomVital in Zaragoza, Spain, seeks a Regulatory Affairs professional to coordinate international product registrations on-site. You will prepare dossiers, manage regulatory documentation, and liaise with distributors and authorities to ensure compliance across markets.

Collaborating with R&D, Quality, Production and Commercial teams, you will set priorities, track timelines and adapt to regulatory changes to support the company's growth.

Qualifications

• University degree in Veterinary Medicine, Pharmacy, Chemistry, Biology, Biotechnology or a related discipline.
• Experience in Regulatory Affairs, preferably with international product registrations.
• Sound knowledge of product registration procedures and regulatory dossiers.

Responsibilities

• Plan, coordinate and manage product registration processes across international markets.
• Prepare and manage technical dossiers and regulatory documentation.
• Coordinate regulatory procedures with distributors, consultants and authorities.
• Assess country-specific regulatory requirements and ensure compliance.
• Manage and monitor existing registrations, renewals and variations.
• Work with R&D, Quality, Production and Commercial teams to ensure documentation accuracy.
• Set priorities, monitor deadlines and track registration timelines.

Skills

Regulatory affairs

English proficiency

Organisational skills

Independent worker

Documentation management

Education

Veterinary/Pharmacy/C Chemistry/Biology/Biotechnology degree

Job description

On-site position based in Zaragoza, Spain.

• Plan, coordinate and manage product registration processes across international markets.
• Prepare and manage technical dossiers and regulatory documentation required to obtain product registrations and authorisations.
• Coordinate regulatory procedures with international distributors, external consultants and competent regulatory authorities.
• Assess country-specific regulatory requirements and ensure compliance with applicable legislation.
• Manage and monitor existing registrations, including renewals, variations and ongoing regulatory maintenance.
• Work closely with R&D, Quality, Production and Commercial departments to ensure the accuracy and compliance of technical documentation.
• Set priorities, monitor deadlines and registration timelines, track regulatory changes and optimise internal regulatory processes.

Candidate Profile:

• University degree in Veterinary Medicine, Pharmacy, Chemistry, Biology, Biotechnology or a related discipline.
• Previous experience in Regulatory Affairs, preferably involving international product registrations within the livestock, veterinary, biocides or animal nutrition sectors.
• Sound knowledge of product registration procedures, technical dossier preparation and regulatory documentation management.
• High level of English, both written and spoken, essential for international communication.
• Strong organisational and planning skills, with the ability to manage multiple projects across different markets simultaneously.
• Ability to work independently, results-oriented mindset, attention to detail and excellent communication skills.

The following will be considered an advantage:

• Experience in the registration of biocides, disinfectants, animal feed additives and animal health-related products.
• Knowledge of regulatory requirements in Latin America, Asia, Africa and the Middle East.
• Experience working directly with international distributors and regulatory authorities.
• Knowledge of additional languages, particularly French.

What We Offer:

• Working arrangement: On-site.
• Working hours: Monday to Thursday, 8:00 am–5:00 pm, and Friday, 8:00 am–3:00 pm.
• Summer working hours (July and August): 8:00 am–3:00 pm.
• A stable, collaborative and professional working environment with genuine opportunities for career development.
• Direct involvement in international projects and SomVital's expansion into new markets.
• A position offering autonomy, responsibility and the opportunity to make a meaningful contribution to the company's growth.