Ra Principal Associate
Lead and execute regulatory strategies for assigned products and projects.
Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority questions.
Ensure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets.
Provide regional regulatory expertise to support global development, CMC, compliance, and labeling activities.
Liaise with regulatory authorities and support regulatory agency interactions.
Collaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teams.
Required Experience & Qualifications:Degree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred).
Minimum5+ years of Regulatory Affairs experiencewithin the pharmaceutical or biotechnology industry.
Strong experience with regulatory submissions and registrations in theEU, UK, and Switzerland.
Experience managing regulatory applications, variations, renewals, and health authority interactions.
Exposure toVeevaand regulatory application management systems is highly desirable.
Experience in vaccines and/or biologics is advantageous.
xysqume
Strong project management, stakeholder management, and communication skills.
English proficiency is required as all Seqirus business is conducted in English
#J-*-Ljbffr
Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority questions.
Ensure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets.
Provide regional regulatory expertise to support global development, CMC, compliance, and labeling activities.
Liaise with regulatory authorities and support regulatory agency interactions.
Collaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teams.
Required Experience & Qualifications:Degree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred).
Minimum5+ years of Regulatory Affairs experiencewithin the pharmaceutical or biotechnology industry.
Strong experience with regulatory submissions and registrations in theEU, UK, and Switzerland.
Experience managing regulatory applications, variations, renewals, and health authority interactions.
Exposure toVeevaand regulatory application management systems is highly desirable.
Experience in vaccines and/or biologics is advantageous.
xysqume
Strong project management, stakeholder management, and communication skills.
English proficiency is required as all Seqirus business is conducted in English
#J-*-Ljbffr