Senior Director, Global Regulatory Affairs CMC
Company Summary:
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 Senior Director, Global Regulatory Affairs CMC to their team. This position will report into the Boston office 5 days per month.
The Regulatory Affairs CMC Senior Director will be responsible for:
- Serving as a member of the GRA-CMC Pharmaceutical Leadership team and establishing a CMC RA strategy.
- Providing leadership of early development pharmaceuticals and in conjunction with direct reports to develop high quality clinical 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 Senior Director should have the following qualifications:
- At least 15 years of Regulatory experience in pharmaceutical industry.
- Experience working with international regulations and major regulatory agencies (i.e. US FDA, EU, PMDA, NMPA, WHO).
