The company 
The client is a global pharmaceutical company standing on three pillars — women’s health, biosimilars and established medicines. Their vision is to create a better and healthier every day.       

Role description 

• Regulatory Compliance and Maintenance: Ensuring the maintenance of European Union marketing authorizations for assigned products by preparing and submitting all necessary post-approval applications, variations, and renewals. This includes coordinating regulatory activities across the EEA, Switzerland, Great Britain, and non-EU EESC countries.
• Documentation and Submission Coordination: Overseeing the preparation and timely submission of regulatory documentation to meet corporate objectives. This includes managing complex submissions such as groupings, super-groupings, and worksharings for various EU procedures (CP, MRP, DCP).
• Agency Interaction: Serving as the primary point of contact for interactions with EU regulatory agencies, including the EMA and country-specific regulatory bodies. 

Responsibilities 

• Regulatory Strategy Development: Developing and executing regulatory strategies for both registered products and new marketing authorization applications, ensuring alignment with corporate goals and compliance with EU regulations.
• Internal Collaboration: Acting as the Regulatory Affairs Europe representative in cross-functional teams and non-product-related projects, maintaining positive relationships with internal stakeholders and ensuring effective communication of regulatory milestones and approvals.
• Labeling and Compliance: Managing labeling variations by coordinating with the EU-LL and preparing English (common) Product Information. Ensure all regulatory submissions and variations meet high-quality standards and comply with applicable EU guidelines.
• Knowledge Maintenance: Staying updated on relevant EU regulations and guidelines, maintaining scientific knowledge and expertise in assigned product areas.

Requirements 

• BSc in Pharmacy or another life science field.
• Minimum of 2 years of experience in the pharmaceutical industry, specifically in a regulatory position, with sufficient expertise to operate with minimal supervision.
• Strong understanding of EU regulations, guidelines, and regulatory processes related to product life cycle maintenance.
• Proficiency in preparing and submitting complex regulatory documentation.
• Excellent interpersonal, oral, and written communication skills.
• Strong organizational and planning abilities, with the capacity to manage multiple projects with shifting priorities.
• Detail-oriented, goal-focused, and capable of working in a cross-functional and international environment.
• Demonstrated ability to adhere to strict project timelines and meet regulatory milestones.
• Strong team player with good judgment and problem-solving skills.
• Proficient in PC use, particularly with RA company systems and tools, word-processing, spreadsheets, and database applications.
• Fluent in written and spoken English. 

Other information  
Apply to our vacancy for more information. Looking forward to getting in touch!