Senior Regulatory Affairs Professional (Denmark, Søborg)

Jobbeskrivelse

Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Your impact begins here
Join us as a Senior Regulatory Affairs Professional and help turn scientific innovation into medicines that can reach patients worldwide. You will guide global regulatory submissions, shape interactions with Health Authorities and contribute to labelling strategies throughout the product lifecycle. Working with colleagues across research, development, safety, clinical operations and commercial functions, you will translate complex requirements into clear regulatory direction and deliver outcomes with global impact.

What you’ll bring
To succeed in this role, you have a strong scientific foundation and relevant experience in pharmaceutical development or Regulatory Affairs.

We expect you to have:

• A master’s degree in life sciences combined with approximately 5-7 years of relevant experience, or a PhD combined with approximately 3-4 years of relevant experience
• Alternatively, a bachelor’s degree in life sciences combined with approximately 8-11 years of relevant experience or equivalent knowledge gained through practical experience
• Experience with regulatory submissions and requirements in one or more major markets, such as the EU, US, China or Japan
• Knowledge of early- or late-stage drug development, lifecycle management, labelling or Health Authority interactions
• Strong written and spoken English
• The ability to interpret complex scientific and regulatory information and communicate it clearly to different audiences
• Confidence working independently, setting priorities and managing several complex deliverables

Experience within areas such as clinical development, pharmacovigilance, medical devices, regulatory intelligence, market access or project management would be useful.

You work with a strategic mindset and can make sound decisions based on risk evaluation. You are structured, accountable and comfortable adjusting your approach in a changing environment. You also build trusting relationships, contribute actively across teams and communicate with professional authority while remaining open to different perspectives.

What you’ll do
Your primary responsibility will be to develop and execute regulatory activities that support global drug development and lifecycle management.

Your key responsibilities will include:

• Planning and coordinating global regulatory submissions, including marketing authorisation applications, clinical trial applications and lifecycle-management submissions.
• Applying regulatory intelligence to develop submission strategies, plans, content structures and timelines
• Preparing regulatory files and coordinating document creation, review, and submission
• Managing responses, commitments and follow-up activities arising from Health Authority
• Planning and supporting interactions with Health Authorities, including meeting requests, briefing packages, rehearsals and formal meeting documentation
• Developing and maintaining core labelling, including the Company Core Data Sheet and European labelling
• Contributing to global regulatory strategies and identifying opportunities to improve methods, processes and regulatory approaches
• Providing regulatory guidance to stakeholders and mentoring less-experienced colleagues when relevant

You will independently manage most situations and take initiative when planning and delivering your work. More complex matters will be addressed in close collaboration with specialists, senior colleagues and your manager.

Who you’ll work with
You will join Regulatory Affairs within Obesity & Cardiometabolic Health and work in a global, cross-functional environment. Your closest collaboration partners may include colleagues from, Clinical reporting, Medical and Translational Science, Clinical Operations, Global Safety, Medical Affairs, Commercial,, Legal, Quality and Regulatory Affairs teams across headquarters and affiliates.

Externally, you may engage with Health Authorities such as the European Medicines Agency, the US Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency and other regulatory agencies worldwide.

The role requires you to create alignment across different professional disciplines, organisational areas and regions. You will often communicate complex or ambiguous information, navigate different interests and help stakeholders reach decisions that support both regulatory requirements and business priorities.

What you can expect here
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. 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.

Salary: For this role, the Annual Base Salary ranges from 651,000 to 956,900 DKK (DK) , corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy here .

Start now
Submit your application byFor further information about the position, please contact 25th October

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