REGULATORY AFFAIRS MANAGER
  21.02.2018 Nº: 054/2018
Sector:

Farmacèutic


Descripció:

REGULATORY AFFAIRS MANAGER

Accord Healthcare SLU (Spain) - Barcelona


Funcions:

Regulatory:

 

1.    Coordination and revision of new MA applications

2.    Follow-up, review and finalization of DCP/MRP/CP national phases

3.    Prices and reimbursement applications

4.    Preparation and review of the packaging material

5.    Review and translation of regulatory documents

6.     Activities necessaries to maintain the marketing authorizations (variations, renewals…)

7.    Submission of safety variations to the Health Authorities

 

Additional duties

 

1.    Coordinate and arrange required documents for the release of batches in Spain

2.    Managing and follow up of quality complaints

3.    Pharmacovigilance activities as per work load requirements.

Providing support to marketing, sales and customer service departments regarding technical issues


Experiència:

De 3 a 5 anys


Aptituds:

Person specification

1.    Scientific background (BSc in science or pharmacy)

2.    At least four years’ experience in regulatory affairs in the pharmaceutical industry. Pan-EU experience would be preferred

3.    Knowledge of Spanish and European regulations on egulatory affairs

4.    Great command of English

 

Skill requirements

 

1.      Scientific background and knowledge of regulatory legislation and guidelines

2.      Team work capacity as well as ability to organize individual work

3.      Management and coordination ability

4.      Ability for a quick adaptation to the changes introduced in the regulatory environment.

5.      Good communication skills

6.    Create and maintain a high quality image of both products and processes


Posició

Sènior


Jornada laboral

Jornada completa


Salari