EU Generalist

Job Summary

This is a remote position.

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

We are currently seeking a dynamic and versatile professional to join our team as an EU Generalist. Below is a comprehensive job description outlining the responsibilities, qualifications, and expectations for this role.

Responsibilities

• Serve as a key point of contact for all matters related to European Union (EU) regulations, policies, and procedures across various functional areas within the organization.
• Monitor and interpret EU regulations, directives, and guidelines applicable to pharmaceutical, biotechnology, and medical device products to ensure compliance and facilitate business operations.
• Provide regulatory guidance and support for product development, registration, and commercialization activities in EU member states, including preparation and submission of regulatory applications (e.g., MAAs, variations, notifications).
• Conduct regulatory assessments and gap analyses to identify compliance risks and develop strategies for addressing regulatory challenges and issues.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and market access, to ensure alignment on regulatory strategy and objectives for EU markets.
• Support the preparation and coordination of regulatory submissions and interactions with EU regulatory authorities (e.g., EMA, national competent authorities), including participation in regulatory meetings and responses to inquiries.
• Stay abreast of emerging regulatory trends, changes, and updates in the EU regulatory landscape and provide insights and recommendations to internal stakeholders.
• Serve as a subject matter expert on EU regulatory requirements and processes, providing training and guidance to internal teams as needed.

Qualifications

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on EU regulations.
• Deep understanding of EU regulatory requirements and procedures for pharmaceutical, biotechnology, and medical device products, including experience with centralized and decentralized procedures.
• Proven track record of successful interactions with EU regulatory authorities, including preparation and submission of regulatory applications and participation in regulatory meetings.
• Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to internal and external stakeholders.
• Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for compliance.
• Regulatory affairs certification (RAC-EU) or relevant professional certification (e.g., TOPRA Diploma) preferred but not required.
• Ability to work independently and collaboratively as part of a multidisciplinary team, with a commitment to delivering high-quality regulatory support and guidance to the organization.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.