Regulatory Affairs Intern

hace 2 semanas


Madrid, España Kenvue A tiempo completo

**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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