Senior Specialist Regulatory Affairs

About Abbott EPD - Established Pharmaceuticals

We are committed to bringing the benefits of our trusted medicines to more people in the worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology womens 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 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: Bachelors or Masters degree in a relevant field.
• Experience: Minimum 3-5 years in Regulatory Affairs or related pharmaceutical/medical field.
• Strong knowledge of medicines registration requirements and regulatory needs.
• Excellent communication skills proactive collaborative and confident in engaging with internal and external stakeholders.
• Project management skills and ability to coordinate cross-functional teams.
• Language: English required Dutch is a plus.

We Are Looking For
We value someone who is curious detail-oriented and not afraid to ask questions. You thrive in a collaborative environment enjoy building relationships across teams and can navigate complexity with confidence. You are a natural problem-solver who takes initiative and communicates clearly even under pressure. If you are adaptable open-minded and passionate about making an impact in global health youll fit right in.

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Local benefit package
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

How to apply

Please send you application through the link in the advertisement. Please note that all applications must include a CV and cover letter.