Regulatory Affairs Specialist (TEMP)

Descripción de la oferta

Functions

· Preparation of OTC regulatory packets for their submission to Health Authorities (new product implementation and maintenance and renewal of product just marketed)

· Preparation of OTC and Cosmetics advertising regulatory packets for their submission to Health Authorities

· Close work relationship with the R&D and Regulatory Affairs franchise in order to implement product launches and/or activities, claims and materials in Spain.

· Establish close work relationship with health authorities.

· Provide with medical and scientific information from regulatory point of view to marketing personnel for promotional activities and review and approve Marketing materials

· Management and updating of the Corporate data base and compliance processes, contributing to define and carry out all the necessary actions which guarantee the Regulatory Compliance.

· Provide scientific and regulatory information on product ingredients to Consumer Affairs upon clients & consumers requests.

· Revision and approval of artworks & product information.

Perfil buscado

Qualifications :

Qualifications and Skills

·  Bachelor's or Master's Degree or above in Pharmacy

·  3 years or more of experience in Regulatory Affairs with Detailed Knowledge of spanish local laws and regulations regarding human medicinal product and comestics

·  Master Degree in Pharmaceutical Industry or Regulatory Affairs would be a plus

·  Excellent level of english

·  Service and result oriented person with a hands-on mentality.

·  Excellent attention to detail

·  Strong interpersonal and organisational skills

·  Proficient with MS tools

·  Strong analytical skills

·  Excellent written and verbal communication skills

·  Ability to work in team and proactive and positive approach to problem solving