Global Regulatory Affairs Manager

hace 5 días

Barcelona, España MCR International A tiempo completo

Descripción del Trabajo / Job Description
- MFC-2402-62
GLOBAL REGULATORY AFFAIRS MANAGER
BARCELONA
Position Summary
Innovative international specialty pharma Company that invests in the development of new treatments for patients through partnerships with third parties. A broad therapeutic portfolio provides help to many patients in need. Although the Company is focused on specialty medicine and the therapeutic areas of neurosciences, oncology and ophtalmology, has also a broad portfolio of products in other therapeutic areas and OTC.
As we expand our portfolio and increase our international presence, we are looking for an experienced International Portfolio Manager within the Global Regulatory Team in Headquarters located in Barcelona.
Main tasks will be related to the definition of regulatory strategy for registration of existing products in new territories and life cycle management of products at international level.

**Responsibilities**:

- Develop and implement regulatory strategy for registration of existing products in new territories at a global level, including assessment of probability of regulatory success for a certain product.
- Establish an effective collaboration with internal commercial stakeholders and partners and ensure business needs and priorities are well understood within the International Reg Affairs Team.
- Lead International Reg Team to ensure objectives are successfully delivered on time, and with good quality standards.
- Track main regulatory activities, and monitor activities are conducted within established deadlines for any new submission, variations, deficiency letters, etc
- Ensure effective regulatory representation (in partnership with appropriate technical experts) in any discussion with Health Authorities, or with any external stakeholder.
- Establish and manage a regulatory network of external consultants and vendors according to business needs.
- Ensure proper communication with other members of Global Reg Affairs Team and other departments on any regulatory need.
- Participate in external opportunities/due diligence
- Prepare and manage budget for the department
- Create a stimulating team environment with an open communication
- Foster Regulatory Intelligence within the department and cross-sharing with other company areas as required.
- Ensure RIMS system and other regulatory tools (e.g. publishing tools) are up to date and properly managed.
- Qualifications
- Education: Bachelor’s degree in life sciences
- Language: Proficiency in English as a business language
- Minimum experience of 8-10 years in International Regulatory Affairs for pharmaceutical products, ideally at a global level.
- Proven ability to manage a team of Regulatory Specialists, coordinate multiple projects, establish priorities and meet critical deadlines.
- Solid knowledge of international registration procedures and pharmaceutical legislation in main territories across the world.
- Proven track record of effective collaboration with partners and Health Authorities in gaining regulatory approvals and managing life cycle of approved products in different geographical areas.
- Experience with Data management systems (e.g. RIMS).

Compartir Posición / Share Position

Detalles / Details
- Ciudad / City
Barcelona
País / Country
ESPAÑA

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