- Ensure compliance with all the relevant regulatory, pharmacovigilance and quality requirements in Europe
- Implement the Regulatory submission strategy in Europe, with a focus on the B2C activities (direct sales in the market)
- Support the new product submissions in Europe, primarily via DCP, and co-ordinate the national phase
- Support the maintenance of granted marketing authorizations and co-ordinate variations
- Liaise with the Global RA, QA and Pharmacovigilance function
- Support the BD function and interact and resolve any Technical Issues with our Customers
- Support the activities of the Qualified Person for Pharmacovigilance (QPPV) and the maintenance of the European pharmacovigilance system, including the population and maintenance of the EMA Article 57 database (xEVMPD):
- Support QA-related activities that are required for the running of the business in Europe such as the maintenance of WDL/MIA licences in Europe, and the establishment of Quality agreements
- Support the method transfer and batch release process in Europe, and ensure co-ordination with the manufacturing sites
- Liaise with European Health Authorities
- Represent the company and the department during interactions with clients, providers and consultants
- Propose and implement new standard operation procedures
- Keep up-to-date with the current EU legislative guidelines
- At least 5 years ́ work experience in a Regulatory Affairs department with significant involvement in EU procedures and, preferably, with exposure to Pharmacovigilance and Quality Assurance & compliance
- Science Degree and preferably a post-graduate Master in Industrial pharmacy
- Excellent written and verbal communication skills. Fluent in English and Spanish, a 3rd European language is a plus
- Strong communication skills and IT fluency; proficient in Word, Excel and Outlook
- Ability to manage complex projects and multi-task
- Excellent organizational skills
- Ability to flourish with minimal guidance, be proactive, and handle uncertainty
- Comfortable using a computer for various tasks
- Being Professional & punctual, well-organised
- Team Player.
- You will join a great project in expansion of a pharmaceutical company with a strong international presence.
- You will develop a profile with European scope and in collaboration with the different international departments of the company.
- Competitive salary
- Hybrid and flexible working mode
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Manager Technical Services Europe - Barcelona, España - Westerman
Descripción
Job DescriptionWesterman is a leading firm of high-value intelligent solutions in the area of executive search whose work philosophy is based on the combination of the boutique model of international headhunting with a strong digital approach based on e-searching.
We collaborate with a company in the pharmaceutical sector with an international presence in the search for an EMEA Regulatory Affairs Specialist.
The main functions to be developed are:
