Regulatory Affairs Intern-2307004145W

Description

Coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies in Spain.

Cooperation with Commercial/Marketing teams.

Medicines Regulatory activities:
• New marketing authorization activities
• Maintenance activities of existing licenses: preparations of administrative, quality regulatory packages and safety related variations for their submission to Healthcare Authorities (H.A.)
• Artwork review and approval with the help of the Regulatory Specialist. Internal Aws tool user.
• Review of promotional materials direct to Healthcare Professionals and consumers.
• New legislation monitoring, impact analysis and communication to business partners.
• H.A. tools: Fraccionamiento (Breaking-up of SPCs and PILs). RAEFAR, LABOFAR

Cosmetic Regulatory activities:
• Artwork review and approval. Internal Aws tool user.
• Review of the promotional... material for Healthcare Professionals, consumers and internal departments
• Scientific advice for promotional materials with the support of the Regulatory contact in the Regional Team
• Product information advice for Consumer affairs and consumer service
• Ensure completion of databases.
• New legislation monitoring, impact analysis and communication to business partners.
• New requests, notification of changes for the maintenance, renewals of National Codes of the CGCOF

Oral care Regulatory activities:
• Renewal of licenses and variations for the maintenance of Hygine products licenses (dental products)

Medical devices Regulatory activities:
• Review of the promotional material for consumers and submission to the HA for approval: CPS
• Review of the promotional material for consumers: Healthcare Professionals
Qualifications

Job Requirements

Essential knowledge and skills:
• Degree in Pharmacy or similar
• Master in Pharmaceutical Industry
• Fluent English

Core competencies

Communication & Knoweledge sharing

Functional Competencies

Driving solutions
Primary Location Europe/Middle East/Africa-Spain-Community of Madrid-Madrid

Organization JNTL Consumer Health (Spain) S.L

Job Function Administration
Madrid Spain

Salary Criteria