Regulatory Affairs Manager

Krka; Madrid; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

Krka is seeking a Regulatory Manager in Madrid, responsible for leading a regulatory team to ensure compliance with local legislation regarding generic medicines. You will manage registration procedures, maintain existing registrations, and communicate with local authorities.

The ideal candidate holds a university degree in Pharmaceutical Sciences or related fields and has a minimum of 3 years of experience in registrations. Fluency in English and Spanish is essential, along with strong attention to detail and organizational skills.

Qualifications

• Minimum 3 years of experience in registrations with knowledge of local and international regulatory procedures.
• Experience working with local authorities and in pharmacovigilance.
• Ability to meet deadlines efficiently while maintaining high accuracy.

Responsabilités

• Leading regulatory team of 2 Regulatory Associates.
• Management of registration procedures for obtaining registrations for generic medicines.
• Communication with local authorities and monitoring pharmaceutical legislation.

Connaissances

Fluent English

Fluent Spanish

Attention to detail

Team-oriented

Self-initiative

Formation

University degree in Pharmaceutical Sciences, Chemistry, Medicine, Vet medicine, Biology

Description du poste

• Leading regulatory team of 2 Regulatory Associates
• Management of registration procedures to obtain registrations for generic medicines in line with local legislation
• Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases
• Translations of SPCs, leaflets and labelling from English to Spanish and vice versa
• Reviewing approved product information in post-registration/production phase
• Planning coordinating and supervising all activities needed for obtaining marketing authorizations
• Communication with local authorities
• Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agency
• Working closely with Regulatory affairs, Pharmacovigilance and QA headquarters and reporting to them

We value candidates with:

• University degree in Pharmaceutical Sciences, Chemistry, Medicine, Vet medicine, Biology
• Minimum 3 years of experience in registrations (knowledge of local and international regulatory procedures and relevant legislation, knowledge of price and reimbursement procedure, working with local authorities, some experiences in pharmacovigilance)
• Fluent English and Spanish
• A person who is team oriented, accurate and good with details, self-initiative, organized and efficient, able to meet deadlines and has an honest, transparent attitude and communication