Publicada en: 14/07/2017
Tipo de empleo: Indefinido
Sector: Farmacéutica y Asistencia sanitaria
 
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The role will define the regulatory strategy of the company to ensure perfect compliance of the products to the various markets.

OBJECTIVE:

Define the regulatory strategy of the company to ensure perfect compliance of the products to the various markets. Manage the necessary regulatory activities to ensure the obtention of Products marketing authorizations and their maintenance in the requested conditions and terms. Contribute to the achievement of the company's objectives in all commercial areas. Coordinates the regulatory areas in the world. (sales in over 60 countries).

INTERACTIONS (internal/external):

  • INTERNAL: All departments and commercial areas.
  • EXTERNAL: Clients, Ministries, Universities, Labs, Regulatory Agencies, Consortiums, Associations and working groups.

REPORTS: Executive Manager

FUNCTIONS:

Strategic: Business development supported on regulatory strategic performance.                                                                                                                                                                                                     

  • Guide, direct and coordinate the strategic planning of the Regulatory Affairs function with the team.
  • Define, propose and implement the regulatory strategy of the company. 
  • Describe regulatory/registration plans according to the company needs and priorities. Coordinate and control the regulatory actions of the Group around the world ensuring compliance and identifying synergies among legal frameworks and markets.
  • Support business planning proposing strategic investment alongside commercial. Department Budget preparation, control and follow up.  Provide regulatory support to all commercial areas.                                                                                                                                                                                                        

Operational: Product registrations worldwide.                                                                                                                                                                                                                                                             

  • Evaluate and interpret regulatory requirements related to scientific research and technical project needs and responsible for disseminating information on changes in regulatory policies for proper management.
  • Conduct Regulatory Affairs (project) activities of managers and specialists, in relation to department's milestones and project deadlines anticipating to.                                                                                                                                                                                      
  • Ensure that regulatory communications comply with corporate and departmental standards with respect to technical excellence.

Product Safety: Marketing products in compliance with safety Regulations.                                                                                                                                                                                                                         

  • Communicate directly with the Authorities (Ministries, European Chemical Agency, ECHA; EU Commission working groups…) in the activities related to the presentation and defense of products. 
  • Ensure that regulatory activities support marketing and sales needs.
  • In charge, of compliance with Safety Regulations; specially REACH (Regulation, Evaluation, Authorization of Chemicals); EC Regulation No 1907/2006 and CLP (Classification, Labeling; Packaging); EC Regulation No 1272/2008

IP (Intellectual Property) & Legal: Brand port-folio protection and liability issues

  • Responsible of the Intellectual/Industrial property at corporate level: Supervisor of the complete brand protection of the company port-folio
  • Support the legal management of contracts and relationship with clients and partners.

EDUCATION: Degree in chemistry / pharmacy / Agronomy / Biology or Postgraduate in Industrial.

REQUIRED EXPERIENCE

  • Experience in the management of work teams in the regulatory field.
  • Excellent contacts with the main decision makers (Sindicates, professional associations...)
  • Deep and thorough knowledge of local  procedures.
  • Desirable to have experience in Technical Management (although not at the level of Technical Director).

YEARS OF EXPERIENCE: 8-10 years

SKILLS

  • High analytical and decision-making capacity.
  • Great ability for teamwork to interact with others within the organization.
  • Orientation to results and clients.
  • Proactive and capable person to take the initiative.
  • Accustomed to team management or, in case of a second level of Department, person who has attitudes and skills to manage teams.
  • Good communication capacity with both internal and external interlocutors.

LANGUAGES:

Spanish + English at negotiation level and another valuable language

OTHER REQUIREMENTS:

Availability to travel according to the needs.

Contact

Luis Díaz-Obregón
+34 91 787 93 08
Hudson
Serrano 240, 1ª planta
28016 Madrid
España

Enviar oferta por correo electrónico

Inscribirme en esta oferta: REGULATORY AFFAIRS DIRECTOR
Referencia: ES_760378

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