about 2 months ago
Job title: Regulatory Affairs Associate - US Respiratory Generics
A global pharmaceutical company in Essex are seeking a Regulatory Affairs Associate. This role will focus on US Respiratory Generic products. This role will prepare ANDAs and related correspondence to the FDA.
- Manage the preparation, compilation and submission of high-quality US controlled correspondence, meeting requests, ANDA filings and responses to FDA.
- Have scope to potentially manage the preparation, compilation and submission of high-quality EU meeting requests, submissions and responses to Competent Authorities.
- Maintain full awareness of all regulatory activities on assigned projects ensuring that project deadlines and performance standards for these projects are established and met.
- Critically review change controls and work closely with all departments at site to obtain the required documentation for upcoming submissions.
- Minimum 2 years Regulatory Affairs experience within a Pharmaceutical organisation
- Experience within Respiratory Generics products would be advantageous
- Experience of US Regulatory environment is essential
Salary and benefits:
A competitive base salary, annual bonus, private medical insurance and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org