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Senior Regulatory Affairs Specialist
hace 7 días
Westerman is a top firm specializing in high-value intelligent solutions in executive search. Our approach combines the boutique model of international headhunting with a strong digital strategy based on e-searching.
We are partnering with a leading company in the pharmaceutical sector with a global presence to fill the role of EMEA Regulatory Affairs Specialist.
The key responsibilities for this position include:
- Ensure compliance with regulatory, pharmacovigilance, and quality standards in Europe
- Develop and execute Regulatory submission strategies in Europe, particularly focusing on B2C activities
- Support product submissions in Europe, especially via DCP, and manage national phase coordination
- Assist in maintaining granted marketing authorizations and coordinating variations
- Collaborate with Global RA, QA, and Pharmacovigilance teams
- Support BD function and address Technical Issues with Customers
- Assist the Qualified Person for Pharmacovigilance and manage European pharmacovigilance system
- Support QA-related activities in Europe
- Manage method transfer and batch release process in Europe
- Liaise with European Health Authorities
- Represent the company during client interactions
- Recommend and implement new operating procedures
- Stay updated on EU legislative guidelines
Requirements:
- Minimum 5 years of experience in Regulatory Affairs with EU procedures exposure
- Science Degree, preferably post-graduate Master in Industrial pharmacy
- Strong written and verbal communication skills in English and Spanish, additional European language is a bonus
- Proficient in Word, Excel, and Outlook
- Ability to manage complex projects and multitask
- Excellent organizational skills
- Proactive, adaptable, and confident working independently
- Proficient in computer use
- Professional, punctual, and team-oriented
Benefits:
- Opportunity to be part of the exciting expansion project of a global pharmaceutical company
- Develop a European-wide profile collaborating with international company departments
- Competitive salary
- Hybrid and flexible work setup
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