Senior CMC Regulatory Affairs Specialist | Biopharma

Placements24; Lorenziberg; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist specialized in CMC to lead global regulatory submissions and ensure compliance across NDAs, MAAs, variations, and annual reports. The role requires coordinating with R&D, manufacturing, QC and QA, interpreting FDA/EMA/ICH guidelines and CTD Module 3, and developing regulatory strategies to accelerate access to medicines.

Office-based in Austria with collaboration across manufacturing teams; strong communication and project management

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, or related field; Master's preferred.
• 6+ years in regulatory affairs with a focus on CMC for pharma/biologics.
• Knowledge of FDA, EMA, ICH guidelines and CTD Module 3.
• Experience preparing and submitting CMC sections of dossiers.

Responsibilities

• Prepare, review, and submit CMC dossiers for NDAs/MAAs and variations.
• Interpret global CMC guidelines and advise on regulatory strategy.
• Collaborate with R&D, manufacturing, QC, and QA to collect data.
• Maintain regulatory documentation and respond to agency inquiries.
• Support SOP development and regulatory meetings.

Skills

CMC submissions

Regulatory affairs

Global guidelines

CTD Module 3

Analytical testing

Education

Bachelor's degree in Chemistry/Pharmacy

Master's degree preferred

Tools

Regulatory information systems

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist specialized in CMC to lead global regulatory submissions and ensure compliance across NDAs, MAAs, variations, and annual reports. The role requires coordinating with R&D, manufacturing, QC and QA, interpreting FDA/EMA/ICH guidelines and CTD Module 3, and developing regulatory strategies to accelerate access to medicines.

Office-based in Austria with collaboration across manufacturing teams; strong communication and project management