Senior Regulatory Affairs Manager, Europe

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 markets
• Working 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 plans
• You 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 products
• You will prepare strategy recommendations lead scientific advice and PIP discussions and co-ordinate agency meeting preparation
• When 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 lifecycle
• You 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 teams
• You 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 requirements
• The ability to translate regulatory complexity into clear commercial strategy
• A collaborative mindset you build relationships as naturally as you build dossiers
• Experience working across global matrix teams and influencing without authority
• A proactive approach to compliance and risk management
• The potential and appetite to mentor junior colleagues as the team grows

Essential Skills and Abilities

• Ability to prioritise and manage workload including managing multiple projects
• Ability to work effectively and collaboratively across the Abbvie organisation

• Experienced in working effectively across cultures and in complex matrix environment
• Good interpersonal and negotiation skills and the ability to influence others
• Travel 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. 

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Work :

No

Employment Type :

Full-time