CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to oversee global regulatory strategies and submissions related to biological and non-biological products. The ideal candidate should have extensive regulatory experience in the biologics or plasma industry, with a strong emphasis on compliance and relationship management with regulatory agencies
Job Summary
The role involves defining global regulatory strategies to support the development and lifecycle management of CSL's biological and non-biological products.
Candidates will represent CSL in official regulatory capacities as an authorized official during interactions with international health authorities.
Joining this agile team means contributing to the development of vaccines that make a meaningful difference worldwide while working onsite three days a week.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to oversee global regulatory strategies and submissions related to biological and non-biological products. The ideal candidate should have extensive regulatory experience in the biologics or plasma industry, with a strong emphasis on compliance and relationship management with regulatory agencies.
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
Biologics product portfolio management
Regulatory submission authoring and review
Change control assessment expertise
Health authority interaction management
Nice-to-have
Innovative regulatory approaches
Cross-functional collaboration skills
Strategic problem-solving abilities
Competitive positioning insights
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years progressive experience in biologics regulatory roles