Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Senior Manager, Regulatory Affairs - Europe

Job Objective

Shape the regulatory future of medicines that matter.

As the Senior Manager, you know the European regulatory landscape. You understand what it takes to get medicines to patients - the strategy, the rigour, the relationship-building, and the relentless attention to detail. We are looking for someone ready to do more than manage submissions. We want someone who leads with intent, thinks several moves ahead, and sees regulatory affairs as a genuine driver of commercial and patient outcomes.

This is a role where your expertise changes what is possible.

What you will be doing

Driving registration strategy across Europe

You will be at the centre of how we bring commercially important products to European marketsWorking closely with your line manager and Area Product Lead, you will define and execute filing strategies - CP, MRP, DCP - identifying risks early and building smart mitigation plansYou will represent the regulatory voice in both Area and Global Regulatory and Project Teams, making sure European requirements are heard, understood, and acted on

Influencing global product strategy

Your insight into European regulatory requirements will directly shape how global teams plan and develop productsYou will prepare strategy recommendations, lead scientific advice and PIP discussions, and co-ordinate agency meeting preparationWhen the global strategy needs a European perspective, you are the person in the room making the argument.

Leading lifecycle management

From CMC to labelling, PSUR to QRD, you will lead regulatory activities that keep products compliant and commercially viable throughout their lifecycleYou will proactively spot compliance risks before they become problems, and you will have the autonomy to drive the remediation

Building relationships that work

Regulatory success in Europe does not happen in isolation. You will build trusted relationships with affiliates, EMA, national health authorities, and cross-functional teamsYou will interface directly with health authorities on behalf of the Product Lead and become the go-to person for regulatory intelligence in your therapeutic area

Supporting development-stage assets

Beyond marketed products, you will also have the opportunity to contribute to European regulatory strategy for pipeline assets - bringing your expertise to bear at the stage where it can have the greatest impact
Qualifications

What we are looking for

A strong track record in European regulatory affairs, with hands-on experience across major regulatory routes (CP, MRP, DCP)Deep knowledge of EMA processes, lifecycle management, and labelling requirementsThe ability to translate regulatory complexity into clear, commercial strategyA collaborative mindset — you build relationships as naturally as you build dossiersExperience working across global matrix teams and influencing without authorityA proactive approach to compliance and risk managementThe potential and appetite to mentor junior colleagues as the team grows

Essential Skills and Abilities

Ability to prioritise and manage workload including managing multiple projectsAbility to work effectively and collaboratively across the Abbvie organisationExperienced in working effectively across cultures and in complex matrix environmentGood interpersonal and negotiation skills and the ability to influence othersTravel approximately 10%
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html