[Hiring] Regulatory Affairs Senior Specialist - Publishing @Ant Talent Ltd

Role Description

We are recruiting for a Regulatory Affairs Senior Specialist – Publishing to join a growing Regulatory Publishing team at an international Contract Research Organization. In this role, you will work closely with one of their R&D clients.

Location: This role can be based remotely (home based) from anywhere in Poland or Bulgaria. This is a full-time, permanent role. The role can be either a specialist or a senior specialist level.

As a Regulatory Publishing specialist, you will play a critical role in the preparation and electronic submission of regulatory dossiers in compliance with local and global health authority regulations, and ICH regulatory and technical guidelines. You will ensure the accurate and timely delivery of high-quality electronic submissions, including:

• CTAs
• INDs
• NDAs
• MAAs
• Other submissions with the FDA, EMA, etc.

Responsibilities

• Lead and manage the publishing and submission of regulatory dossiers (e.g., CTAs, INDs, NDA, BLA, MAAs) to regulatory authorities, ensuring regulatory compliance with local and international guidelines.
• Ensure publishing documents and submissions meet the electronic document requirements set by regulatory authorities, ensuring consistency.
• Prepare and format submissions in eCTD format, ensuring all regulatory documents are appropriately formatted, organized, and meet technical requirements.
• Conduct thorough quality control reviews of submission documents to ensure accuracy, consistency, and compliance.
• Evaluate publishing needs and use professional judgment in relation to overall project quality, delivery, and timelines.
• Maintain submission documents throughout their life cycle, ensuring they are well-managed throughout the preparation and submission phases.
• Assist and collaborate in the company’s execution of regulatory submission strategies, acting as the company’s liaison for regulatory submissions with the sponsor.
• Provide training and guidance to junior publishing staff, fostering best practices in regulatory publishing and submission management.
• Collaborate with the publishing team and cross-functionally as necessary to deliver final products on time and resolve identified issues or barriers to submission.

Qualifications

• Bachelor’s degree in life sciences or a related field. Advanced degree or relevant certifications are a plus.
• Minimum of 4-5 years of regulatory publishing experience or a related field with focus on document formatting and electronic submission.
• In-depth knowledge of Microsoft Office – Word, Excel, as well as Adobe Acrobat, electronic document management systems (EDMS), publishing systems, and tools.
• Experience with eCTD submission processes and associated software tools.
• Knowledge of electronic templates and skills in formatting and troubleshooting them.
• Strong editorial and proofreading skills.
• Advanced understanding of regulatory submission standards (ICH, FDA, EMA) and region-specific guidelines.
• Excellent project management and organizational skills, with the ability to manage multiple projects with changing priorities and meet strict deadlines.
• Detail-oriented with a strong focus on quality and compliance.
• Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.
• Ability to mentor and guide junior team members.
• Strong verbal and communication skills. Fluency in English.

Benefits

• Competitive Salary and Benefits: Attractive compensation package, including health insurance, pension plans, and more depending on your location.
• Professional Development: Opportunities for continuous learning and career advancement in a supportive, collaborative, and innovative environment.
• Impactful Work: Contribute to groundbreaking research that makes a real difference in patients' lives.
• Collaborative Culture: Join an international team of passionate professionals dedicated to excellence in clinical research.