Medical and Regulatory Affairs Director Iberia

hace 1 semana

Barcelona, España Ipsen Pharma SA A tiempo completo

At Ipsen, we are looking for a **Medical and Regulatory Affairs Director Iberia **based in** Barcelona**.

Following the general strategies of the company and the department guidelines, as well as all the procedures and policies, current legislation, code of conduct, and deontology.

Your main responsibilities will be:

- ** Medical Director**
- To promote the relationship and support to our Central through the Europe structures, franchises, IPSEN Community Medical and R & D
- To supervise the clinical studies performed by IPSEN-PHARMA.
- To ensure medical advice to BUs to provide correct information about the products of the Company.
- To guarantee the proper operation of the Pharmacovigilance Service.
- To implement the annual budget.
- To comply with the IPSEN PHARMA policy regarding donations.
- Manage the Medical Department team.
- ** Regulatory Management**
- To supervise that the Company fulfill the responsibilities of the regarding Ownership, Technical Direction, Storage and Distribution of medicines and health products within the European and national legislative framework.
- To manage and monitor the quality of Ipsen products in Spain and the pharmaceutical license of the Company, acting as a contact in quality for the Ipsen Group (Global Quality Assurance) and for the Health Authorities in Spain. Inform the Company management.
- To manage the review the promotional pieces of the Ipsen Pharma products to meet the requirement of scientific service, and ensuring compliance with the Ipsen Group and the Health Authorities regulations by:

- Monitoring the promotional review process and reporting to Health Authorities.
- The information to the management of the Company.
- Act as technical / regulatory contact for the Ipsen Pharma products in front of the Health and Government Authorities in support of the General Manager.
- Manage the Regulatory Affairs team.

**¿Who are we looking for?**:
**Requirements**:

- Degree in Medicine and Surgery.
- Master in Pharmaceutical Industry/Clinical trials.
- Master or Postgraduate in Regulatory/Quality.
- Knowledge of the Pharma sector.
- Minimum 2 years’ experience as Director in Medical Department of Pharmaceutical Industry with experience in team management.
- English - advanced.
- MS Office user level. Advanced Excel
- Based in Barcleona
- Availability to travel

**Key competencies**:

- Strong leadership, communication and influencing skills and commitment to compliance with the ethical and regulatory requirements accordingly health authorities and Ipsen.
- Strategic Thinking (e.g to understand KOL needs, identify issues and opportunities, develop targeted multifaced solutions)
- Strong analytical and numerical skills and an ability to execute plans and achieve outcomes in accordance with deadlines.
- Demonstrated capacity to build strong relationships across functions and to work closely with all people across the business.
- Good understanding of the Guidelines of the Company as well as at Regulatory, promotion, Clinical Trials and Medical Information level.
- Good capacity of team management focused on people development and responsibility.
- **All the CVs must be sent in English.**

**¿What do we offer?**

Working at Ipsen means joining a global biopharmaceutical group focused on innovation and specialized care in three key therapeutic areas: oncology, neuroscience, and rare diseases.

Ipsen's Human Resources policy pays special attention to ensuring that all employees have good working conditions, including a flexible schedule model, training, and development programs, as well as social benefits and committed remuneration based on three main principles: internal equality, external competitiveness, and recognition of work.

**CONTRAT**:
Permament - full time

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