Regulatory Publishing Manager

Talent Groups; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Talent Groups in Boston is seeking a seasoned eCTD publishing specialist to oversee submission readiness and ensure compliance with health authority guidelines. You will balance multiple programs, educate team members, and influence cross-functional stakeholders to deliver timely, submission-ready packages.

The role emphasizes strong organizational and communication skills, attention to detail, and ability to adapt to evolving regulatory requirements in a fast-paced environment.

Qualifications

• Experience with eCTD publishing and validation systems.
• Knowledge of Global HA submissions guidelines and requirements.
• Ability to meet firm deadlines and adapt to changing requirements and priorities.
• Ability to prioritize portfolio of publishing activities on programs.
• Ability to educate and train other team members and influence cross functional stakeholders in submission ready concepts.
• Strong organization, written/verbal communication, and attention to detail.
• Knowledge of health authority procedures/guidance regarding electronic submissions.
• Highly skilled in use of Electronic Document Management Systems.
• Ability to balance multiple tasks to meet priorities and timelines.

Skills

Experience in industry standardpubl~?

Education

Bachelor’s Degree in life sciences or technology area

Typically requires 7 Years of eCTD publishing experience or the equivalent combination of education and experience

Job description

• Experience in industry standard publishing software and validation systems
• Knowledge of types of Global HA submissions and their requirements and guidelines
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Ability to prioritize portfolio of publishing activities on programs
• Ability to educate and train other team members and influence cross functional stakeholders in submission ready concepts
• Strong organization, written/verbal communication, and attention to detail
• Knowledge of health authority procedures/guidance's regarding electronic submissions
• Highly Skilled in use of Electronic Document Management Systems
• Ability to balance multiple tasks to meet priorities and timelines

Education and Experience:

• Bachelor’s Degree in life sciences or technology area
• Typically requires 7 Years of eCTD publishing experience or the equivalent combination of education and experience