Job Title: Regulatory Affairs Specialist
Salary: $75,000 - $85,000, plus bonus
Job Overview: This position is the primary Quality Assurance/Regulatory Affairs department support for maintaining company regulatory submissions. Specific efforts will be the preparation and submission of drug master files (DMF) as well as DMF/ASMF maintenance. This individual will be responsible for the composition of annual product quality reviews for company API and Excipient products as required by ICH Q7. Responsible for providing initial current Good Manufacturing Practice (cGMP) training for all new employees working on site, permanent as well as temporary contract employees. In addition, the individual will also be the primary support for Quality Assurance review of test method and stability protocols and reports. Support quality assurance functions as needed.
- Operate in accordance and compliance with:
- Current cGMP regulations and ICH Q7 guidelines
- Quality Policies (QP), and Standard Operating Procedures (SOP)
- Cardinal Rules of Quality, Delivery and Safety
- Drug Master Files (DMF) / Active Substance Master File (ASMF)
- Prepare and submit drug master files for submission to applicable regulatory agencies. (i.e. US, Europe, China, etc.)
- Maintain the drug master files program via amendments (and annual reports to the FDA or other regulatory agencies as required).
- Work with appropriate company personnel in response to any possible deficiencies noted by a regulatory agency.
- Annual Product Quality Reviews
- Prepare annual product quality review reports for API and Excipient products.
- Work with appropriate personnel to investigate and resolve any adverse product related issues that may be revealed by the annual product quality review.
- Review of Protocols and Reports
- Perform Quality Assurance review of protocols and reports to ensure compliance with standard operating procedures and regulatory guidelines. These include but are not limited to:
- Test method validation protocols and method validation reports
- Stability protocols and stability reports
- Process validation reports and instrument qualification reports
- Quality Assurance Functions
- Support day-to-day quality assurance functions. Including but not limited to:
- Communicate effectively with regulatory agencies is support of regulatory submissions
- Communicate effectively with in-country agents for regulatory submissions
- Communicate effectively with customers when needed
- Communicate effectively with internal departments obtain necessary information for regulatory submissions.
- Perform second checks for analytical results prior to product release
• Bachelor’s degree and/or 5+ years regulatory experience in pharmaceutical manufacturing including drug master file preparation, submission, and maintenance experience.
• Experience in supervising personnel would be helpful.
• Team leadership and project management skills necessary.
• Good observation, organization, prioritization, and problem-solving skills.
• Working knowledge of the cGMP regulations, FDA and ICH Guidelines, and industry standards.
• Experience with global submissions with ASMFs.
• Strong working knowledge of drug master files and annual quality reports.
• Good computer skills (Database, Word, Excel and Windows based programs associated with compliance tracking).
• Strong communication skills (oral and writing strength).
• 1+ years experience utilizing GlobalSubmit Regulatory Submission software.
• Effectively communicates with supervisor and team members and other departments