Remote EU Regulatory Affairs Generalist

Pharmavise Corporation; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Remote work

Job summary

PharmaviseConsulting Corp. seeks a dynamic EU Generalist to support regulatory affairs for pharmaceutical, biotechnology and medical device clients in a remote capacity. You will monitor EU regulations, guide submissions, and ensure compliant development through commercialization.

Collaborating with regulatory, quality, and clinical teams, you will advise on centralized and decentralized procedures and participate in interactions with EMA and national authorities to drive compliant outcomes.

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 pharma, biotech, or medical device with EU focus.
• Deep understanding of EU regulatory requirements and procedures for pharma, biotech, and medical devices, incl. centralized and decentralized procedures.
• Proven track record with EU regulatory authorities and submissions.
• Excellent communication and interpersonal skills across stakeholders.
• RAC-EU or TOPRA Diploma preferred but not required.
• Ability to work independently and with multidisciplinary teams.

Responsibilities

• Serve as a key contact for EU regulations across multiple functions.
• Monitor and interpret EU regulations, directives, and guidelines to ensure compliance.
• Provide regulatory guidance for development, registration, and commercialization in EU member states, including MAAs, variations, and notifications.
• Conduct regulatory assessments and gap analyses to identify risks and develop mitigation strategies.
• Collaborate with cross-functional teams to align regulatory strategy and objectives for EU markets.
• Coordinate regulatory submissions and interactions with EMA and national authorities.
• Stay updated on EU regulatory changes and advise internal stakeholders.
• Serve as SME on EU regulatory requirements and provide training to internal teams.

Skills

EU regulatory affairs

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Regulatory databases

Document management systems

Job description

PharmaviseConsulting Corp. seeks a dynamic EU Generalist to support regulatory affairs for pharmaceutical, biotechnology and medical device clients in a remote capacity. You will monitor EU regulations, guide submissions, and ensure compliant development through commercialization.

Collaborating with regulatory, quality, and clinical teams, you will advise on centralized and decentralized procedures and participate in interactions with EMA and national authorities to drive compliant outcomes.