Senior Regulatory Affairs Specialist
hace 1 semana
Westerman 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:
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 3 rd 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.
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