Regulatory Affairs and Pharmacovigilance Associate Director

This role is where regulatory strategy becomes a growth engine for BASAC, and pharmacovigilance translates into an improved patient experience. When you step into this position, you’ll turn complex frameworks into clear, value-led pathways—helping teams move faster, launch stronger, and bring treatments to patients sooner. If you thrive in a high-autonomy leadership role—shaping decisions, influencing senior stakeholders, and delivering tangible impact at scale—this is your next move.

Your new department

As part of Medical, Marketing & Regulatory, PV for BASAC – you will join a dynamic team where regulatory strategy meets commercial ambition. Here, we're not just ensuring compliance; we're actively shaping how regulatory intelligence drives business decisions and accelerates access to life-changing treatments across the region.

Your new role

As Regulatory Affairs and Pharmacovigilance Associate Director, you'll hold senior strategic leadership accountability for Regulatory Affairs across BASAC, with oversight of Pharmacovigilance. Your primary value lies not in hands-on execution, but in your ability to connect regulatory decisions to business outcomes and strengthen credibility across the MMR organization.

Your key responsibilities will include:

• Owning the Regulatory Affairs strategy for BASAC with high autonomy, driving strategic alignment across new product registrations and lifecycle management
• Providing strategic oversight of Pharmacovigilance, with execution supported by experts and hubs
• Actively contributing to commercial and marketing discussions, constructively challenging initiatives to accelerate time-to-market
• Leading and developing senior managers with strong technical expertise, shifting the function from enable-only to challenge and shape
• Translating regulatory complexities into clear business trade-offs and opportunities that influence Loss of Exclusivity (LoE) strategies
• Representing the organization in regional trade associations and selectively engaging with Health Authorities

Required experience

We're looking for a strategic leader who can build credibility with senior stakeholders and transform how Regulatory Affairs shows up in commercial discussions. You'll bring with you:

• 8–12+ years of experience in Regulatory Affairs, preferably within the pharmaceutical industry, with proven ability to connect regulatory decisions to business outcomes
• Experience leading manager-of-managers or very senior teams, with strong stakeholder management skills and the ability to challenge senior business leaders constructively
• Regional or multi-country exposure, with working knowledge of regulatory processes (dossiers, variations, labeling, Health Authority interactions) at decision level
• Strong strategic mindset that enables you to translate regulatory frameworks into business opportunities and accelerate time-to-market
• Fluent English

Nice to have:

• Pharmacovigilance exposure (developable).
• Pharma + Consumer / OTC exposure.
• Spanish language skills (nice to have; willingness to learn sufficient).
• Experience in environments undergoing mindset or cultural transformation.

What success looks like

• Builds credibility with senior direct reports within 6–9 months.
• Shifts the function from enable only → challenge and shape.
• Accelerates time‑to‑market through smarter regulatory strategy.
• Improves how Regulatory shows up in commercial discussions.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information

For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. To complete your application, click on "Apply now", attach your CV and follow the instructions.

Deadline

Please apply before April 27th, 2026. Applications are reviewed on an ongoing basis.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare.

We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.