What are the responsibilities and job description for the Regulatory Associate position at Exela Pharma Sciences?
Position Summary
The Regulatory Associate is an entry level position that will assist in compiling, reviewing and submitting applications, amendments, deficiency responses and/or lifecycle changes (focus on CMC and Labeling) to the FDA.
Job Responsibilities
- Develop an understanding of the drug development processes within Exela
- Gain familiarity with the documentation and data associated with manufacture of products (compounding, QC analytical chemistry, QC microbiology)
- Assist senior Regulatory Affairs personnel in compilation of regulatory submissions such as annual reports, supplements, amendments for ANDAs and NDAs that will be submitted to FDA as per the business needs and compliance with all FDA requirements
- Reviews change controls for regulatory impact and documentation to be included in regulatory submissions (i.e., batch records (manufacturing, packaging), specifications, analytical methods, etc.)
- Performs thorough review of peer submissions to ensure submission quality and compliance with current guidances and regulations
- Stays current with emerging regulatory guidance, industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices
Experience Requirements
- 2 years pharmaceutical experience
- Read and understand complex regulations and requirements, and develop pragmatic compliance solutions
- Strong problem-solving skills and follow-through
- Strong oral and written communication skills, including making presentations, delivering training, writing/reviewing documentation
- Complete work both independently and as an effective member of the team, adapting to changing requirements, deadlines, and priorities as needed
- Computer skills: MS Office, Excel, PowerPoint, Adobe PDF
Education Requirements
Bachelor’s degree in related field required (biology, chemistry, pharmaceutical science)
