Regulatory Affairs Officer Pharma

hace 11 horas

Barcelona, España Page Personnel España A tiempo completo

Reporting to the Regulatory Affairs Manager, he/she will be responsible for preparing, managing and submitting the documentation required within a registration dossier to the Health Authorities, in accordance with the current legislations.
- Report to Head of Regulatory Department
- Capability to maintain fluid and frequent contact with the client & to find optimum way to meet their expectations
- Data-entry of clinical trials
- Review of promotional material, packaging & labelling
- Submissions of IMAAs (CP, DCP, MRP) variations, renewals, transfers and local procedures initial and follow up activities in Spain and for all EU market
- Cosmetics registration, Product safety reports, management of CPNP databases, labelling review etc.
- Labelling and promotional materials review, support on clasification, notification of commercialization, _Post Commercialization Support_ of medical devices, obtention and registration of all economic agents at European and national level
- Assist the Project Manager in project planning and organization
- Pricing and Reimbursement solicitudes, contact with Ministry of Health
- Due diligence of the dossiers
- Provide strategic Regulatory Advice to clients

1-2 years experience in Regulatory Affairs Pharma|Fluent English
- **1-2 years experience in Regulatory Affairs Pharma** departments. Preferably in the area of **medical devices and cosmetics.**:

- **Fluent English.**:

- Proactivity, good communication skills (written and verbally), capability to point out issues and provide potential options for solution in the area of expertise.
- Ability to prioritize and manage own time and tasks.
- Attention to detail, capability to resolve problems in a thorough and timely manner.

Barcelona based pharmaceutical consultancy with extensive experience in the sector providing consulting, coordination and/or management services in regulatory affairs, pharmacovigilance and quality assurance.
- Barcelona based
- Multidisciplinary team with a strong scientific background.
- You will join a creative, innovative, rigorous, cohesive and pro-active team.

Barcelona based pharmaceutical consultancy is looking to hire a Regulatory Affairs Officer with 1-2 years experience.

Barcelona based pharmaceutical consultancy is looking to hire a Regulatory Affairs Officer with 1-2 years experience.

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