Regulatory Affairs Senior Specialist

September 19

Apply Now

Receive Emails with Similar Jobs

Ant Talent

WebsiteLinkedInAll Job Openings

Recruitment • Medical Writing • Regulatory Affairs • Regulatory CMC • Executive Search

2 - 10

Description

• Lead and manage regulatory dossiers submissions • Ensure compliance with guidelines • Prepare and format submissions in eCTD format • Conduct quality control reviews of submission documents • Maintain submission documents throughout their life cycle • Collaborate with teams for on-time delivery

Requirements

• 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-dept 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

• Attractive compensation package, including health insurance • Pension plans • More depending on your location