Abbott
Pharmaceuticals
SeniorSpecialistRegulatoryAffairs
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“Senior Specialist Regulatory Affairs at Abbott. Skills: Regulatory strategy, Regulatory submissions, Labeling strategies. Define, develop, and maintain pre-clinical, clinical, and labeling strategies for influenza vaccines in line with business objectives.. Implement regional and global regulatory strategies, particularly for labeling and clinical modules.”
Industry & Context.
Natural problem-solver
What They're Looking For.
Must Have
Minimum 3-5 years in Regulatory Affairs or related pharmaceutical/medical field, knowledge of medicines registration requirements and regulatory needs, English required
Nice to Have
Dutch is a plus
What You'll Do.
and maintain pre-clinical
and labeling strategies for influenza vaccines in line with business objectives.
Implement regional and global regulatory strategies
particularly for labeling and clinical modules.
Chair the Labeling SubTeam (LST) for influenza vaccines
participate on behald of Regulatory Affairs in the Product Safety Team (PST) for influenza vaccines and 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 for EU Annual Strain Update variation applications.
Serve as the regulatory liaison throughout the product lifecycle
ensuring smooth approvals for MAAs
How You'll Work.
Team & Collaboration
Collaborate with Global Pharmacovigilance; Coordinate cross-functional teams; Engaging with internal and external stakeholders; Thrive in a collaborative environment; Enjoy building relationships across teams
Communication Scope
Excellent communication skills; Proactive, collaborative, and confident in engaging with internal and external stakeholders; Communicates clearly, even under pressure
Process & Methodology
Project management skills, Ability to coordinate cross-functional teams
Full Job Description
## **JOB DESCRIPTION:** **About Abbott EPD - Established Pharmaceuticals** We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. Are you passionate about regulatory strategy and ensuring compliance for life-saving vaccines? We are looking for a **Senior Specialist Regulatory Affairs** to join our Global Regulatory Development Strategy (GRDS) team, focusing on Respiratory and Vaccines. In this role, you will be a key expert driving regulatory strategies and submissions for influenza vaccines across Developed and Emerging Markets. **Location:** Weesp, Netherlands. This is an onsite office-based position. **What You Will Do** * Define, develop, and maintain pre-clinical, clinical, and labeling strategies for influenza vaccines in line with business objectives. * Implement regional and global regulatory strategies, particularly for labeling and clinical modules. * Chair the Labeling SubTeam (LST) for influenza vaccines, participate on behald of Regulatory Affairs in the Product Safety Team (PST) for influenza vaccines and 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. **Qualifications / Background** * Educational background: Bachelor’s or Master’s degree in a relevant field. * Experience: Minimum 3
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