Senior Manager Regulatory Affairs
Company Summary:
My client, a growing pharmaceutical manufacturing company specializing in intranasal pharmaceuticals, is looking to add a Senior Manager to their Regulatory team. My client is allowing for this role to be hybrid!
The Senior Manager will be responsible for:
- Developing and maintaining Regulatory Systems and assuring compliance with FDA and EU regulations
- Collaborating with departments regarding regulatory concerns and supporting regulatory inspections and customer audits
- Tracking, compiling, and maintaining site regulatory files
- Creating and reviewing regulatory documents in CTD format
- Managing product life cycle through post approval submissions
The Senior Manager should have the following qualifications:
- A bachelor's degree in a scientific discipline with 10+ years of Pharmaceutical Regulatory experience
- An understanding of US and EU regulations and guidance documents
- Knowledge and experience with preparation of regulatory dossiers (IND, Annual Report, ANDA, NDA)
- Experience with Medical Device filings and knowledge of cGMPs and pharmaceutical plant equipment
- Can work with controlled substances
Benefits/Perks:
- Casual dress/atmosphere
If you are interested in this position, please apply today and do not hesitate to contact me with any questions!
