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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director Regulatory Affairs, Europe Regulatory Affairs, Global Regulatory Strategy (GRS) - Oncology

Maidenhead, United Kingdom Req ID 2207932 Category Regulatory Affairs Division AbbVie

Would you like to leverage your regulatory knowledge and experience to help deliver innovation for cancer patients? Are you passionate about playing a pivotal regulatory role in bringing oncology/haematology medicines to patients? 

We have an exciting opportunity for an Associate Director Regulatory Affairs, Europe Regulatory Affairs which is part of Global Regulatory Strategy (GRS) organisation.  The role would cover EU and some non-EU countries such as UK, Israel, Switzerland and Turkey.

You will work collaboratively with key stakeholders within AbbVie (e.g. global regulatory, commercial, market access, clinical and labelling)  and its partners to make a positive difference on patients’ lives. You will define and implement regulatory strategy, for early, and late development compounds and marketed products in Oncology / Haematology

As Associate Director, reporting into the Therapeutic Area Head, Europe Regulatory Affairs, Global Regulatory Strategy you will work closely with the Global Regulatory Project Team (GRPT) in formulating regional regulatory strategy and delivering on EU Marketing Authorisation submission and approval and maintenance thereafter.

Qualifications:

We are looking for an experienced regulatory professional with a proven track record of leading end-to-end strategic planning, coordination, and execution of initial marketing authorisation application/s and new indications in Europe. In this role, you will be the lead contributor to regulatory strategy for Europe and expected to clearly identify submission pathway, risks and opportunities to Global Regulatory Project Team (GRPT) and cross-functional teams, working flexibly within Europe and other regions to ensure successful execution of the regulatory strategy.

At AbbVie we believe diverse minds and inclusive environment is key to delivering impactful business outcomes. Our mission is to have remarkable impact on people’s lives. Within the Oncology Therapeutic Area, we are committed to transforming standards of care in treatment and management of cancers through innovation, dedication and patient centricity. We are focusing on advancements of several NMEs across a range of cancers to get the medicines to our patients and health care providers as quickly as possible.

Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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