Senior Specialist Regulatory Affairs
Abbott
Weesp
16 Mar 2026
Senior Specialist Regulatory Affairs
Senior Specialist Regulatory Affairs role at Abbott EPD focusing on influenza vaccines. Responsibilities include developing regulatory strategies, chairing labeling teams, and ensuring compliance. Requires 3-5 years in Regulatory Affairs, strong knowledge of medicines registration, and excellent communication skills.
On-site
Full-time
Senior
Regulatory Affairs
Medicines Registration
Salary
Not specified
Core Qualifications
Technical (Must-have)
Regulatory Affairsmedicines registrationregulatory strategycomplianceproject management
Soft Skills
communicationcollaborationproblem-solvinginitiativeadaptabilitydetail-oriented
Key Responsibilities
- Define, develop, and maintain pre-clinical, clinical, and labeling strategies for influenza vaccines
- Implement regional and global regulatory strategies, particularly for labeling and clinical modules
- Chair the Labeling SubTeam (LST) for influenza vaccines
- Participate on behalf of Regulatory Affairs in the Product Safety Team (PST) for influenza vaccines
- Oversee creation and maintenance of CCDS and labeling documentation for current and new influenza vaccines
- Monitor and implement relevant regulatory agency guidance to ensure compliance
- Collaborate with Global Pharmacovigilance to complete and submit annual PSURs for influenza vaccines in the EU
- Lead timely completion of Module I for EU Annual Strain Update variation applications
- Serve as the regulatory liaison throughout the product lifecycle, ensuring smooth approvals for MAAs, renewals, and variations
Regulatory AffairsPharmaceuticalVaccinesInfluenzaComplianceLabelingHealthcareFull-timeOn-siteSenior