Head of Regulatory Affairs
About NMD Pharma
NMD Pharma is a clinical-stage biotech company dedicated to developing novel and improved treatments for people living with neuromuscular diseases. The company is advancing a first-in-class platform of small molecule therapies targeting the skeletal muscle chloride ion channel ClC-1 to improve muscle function and quality of life for patients with significant unmet medical needs.
Headquartered in Aarhus, Denmark, NMD Pharma combines deep scientific expertise in muscle physiology and neuromuscular disorders with a collaborative and entrepreneurial culture focused on advancing innovative therapies through clinical development.
The Position
Reporting to the Chief Medical Officer, the Head of Regulatory Affairs will lead regulatory strategy for NMD Pharma’s late-stage neuromuscular programme across the US and Europe.
This is a highly visible leadership role requiring both strategic leadership and hands-on execution in a lean biotech environment. You will work closely with Clinical Development, Clinical Operations, Data Sciences, Safety, CMC, Medical Writing, and external partners to ensure successful health authority interactions, submission readiness, and programme alignment.
Key Responsibilities- Lead and execute global regulatory strategy for late-phase development and registration activities.
- Drive FDA and EMA interactions, including pre-Phase 3, Scientific Advice, pre-NDA/BLA, and filing readiness meetings.
- Lead, develop, and inspire a high-performing team, fostering a culture of collaboration, accountability, and continuous development
- Lead preparation of briefing books, regulatory questions, agency responses, and negotiation strategies.
- Ensure regulatory feedback is translated into clinical, statistical, operational, safety, and CMC plans.
- Own regulatory submission planning and oversight, including IND maintenance, CTA activities, DSURs, and future NDA/BLA/MAA preparation.
- Establish and manage an efficient outsourced Regulatory Operations model and external vendor oversight.
- Partner cross-functionally to ensure clinical development and CMC plans support registration objectives.
- Lead strategy for relevant regulatory designations including Orphan Drug, Fast Track, Breakthrough Therapy, PRIME, and paediatric plans where applicable.
- Significant Regulatory Affairs experience within biotech and/or pharma.
- Proven experience leading regulatory strategy for pivotal or Phase 3 programmes.
- Strong FDA interaction experience and working knowledge of EMA pathways.
- Experience supporting major submissions, such as NDA or MAA.
- Strong understanding of clinical development, safety, biostatistics, and CMC interfaces.
- Highly experienced leader with the ability to support and develop the Regulatory Affairs team.
- Experience operating in a small or mid-sized biotech environment.
- Advanced scientific or medical degree preferred.
- Neuromuscular and/or rare disease experience strongly preferred.
Personal Competencies
You are a strategic and collaborative leader who combines scientific credibility with operational discipline. You bring:
- Strong communication and stakeholder management skills.
- The ability to build trust, engagement, and commitment through authentic leadership and communication.
- The ability to influence across functions and external partners.
- A pragmatic and solution-oriented mindset.
- Regulatory leadership, credibility, and confidence in health authority and senior stakeholder interactions.
Why Join NMD Pharma?
This is an opportunity to play a key role in shaping the regulatory path for a late-stage neuromuscular programme with meaningful patient impact.
At NMD Pharma, you will join a collaborative and science-driven organisation where you can influence strategy, work closely with senior leadership, and contribute directly to the company’s future growth.
Application
Please submit your application and CV as soon as possible. Applications are reviewed on an ongoing basis.
NMD Pharma is committed to creating an inclusive workplace and welcomes applications from all qualified candidates.
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