Director, Global Regulatory Affairs CMC - Oligoncletides
My client is a large, global leader in the pharmaceutical industry committed to delivering life changing treatments for diseases of many different therapeutic areas including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. They are looking to add a Director of Global Regulatory Affairs CMC - Oligoncletides to their team. This position will report into the Boston office 5 days per month.
The Regulatory Affairs CMC Director will be responsible for:
- Leading the GRA CMC Pharmaceuticals - oligonucleotides regulatory team and developing/implementing global CMC regulatory strategies.
- Providing leadership of GRA CMC pharmaceuticals - oligonucleotides and in conjunction with direct reports to develop high quality clinical, commercial, and LCM submissions.
- Building and maintaining relationships with key internal (GRA, GRA CMC, Pharmaceutical sciences, etc.) and external (health authorities, industry counterparts/associations) stakeholders.
The Regulatory Affairs CMC Director should have the following qualifications:
- At least 10 years pharmaceutical Regulatory CMC experience.
- Experience liaising with Regulatory agencies and having served as the lead in agency interactions is preferred.