Regulatory Affairs Intern
hace 2 semanas
**Regulatory Affairs Intern**-2307004145W
Description
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
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