Regulatory Affairs
Regulatory Principal Specialist, RA CMC Development, Copenhagen
Opportunity summary
Shape the regulatory strategy of tomorrow's medicines. Join RA CMC Development and lead at the forefront of an exciting pipeline spanning proteins and peptides, small molecules, antibodies, oligonucleotides and gene therapies, accelerating innovation from science to patients. Are you a highly experienced Regulatory Affairs expert with deep expertise in CMC and global regulatory strategy?
Do you thrive in a complex international environment where scientific insight, strategic leadership, and collaboration are essential to bringing innovative therapies to patients worldwide? If so, we may have the perfect opportunity for you.
Your new role As Regulatory Principal Specialist in RA CMC Development, you will serve as a recognized regulatory expert, providing strategic leadership across global and early development activities. You will be responsible for driving regulatory submissions, influencing health authority interactions, and ensuring regulatory strategies support business and patient needs worldwide.
Your responsibilities will include
- Leading global regulatory CMC strategies and execution for early development across indications and modalities. - Managing interactions with global health authorities, including preparation of briefing documents, regulatory meeting strategies, and responses to agency questions1 …
This is a shortened extract from the public vacancy. Follow the original posting for the complete and authoritative description.