Regulatory Affairs Specialist
JOB SUMMARY
This position is the primary Quality Assurance/Regulatory Affairs department support for maintaining 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 API and Excipient products as required by ICH Q7. This individual will be 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. This individual will also support quality assurance functions as needed.
location: Waukegan, Illinois
job type: Permanent
salary: $115,000 - 120,000 per year
work hours: 8 to 4
education: Bachelors
responsibilities:
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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 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.
- Quality Assurance Functions
- 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
- Review instrument calibration records
- Assist colleagues, substitute for colleagues when absent
- Write/update standard operating procedures
- Assist with audits as requested (i.e. obtaining requested documents)
- Participate and lead internal audits of Quality Systems
qualifications:
QUALIFICATIONS
- 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 preferred.
- Effectively communicates with supervisor and team members and other departments
- Must have good hearing and sight - adequate for safety programs in a pharmaceutical manufacturing plant.
- Must be able to sit and/or stand for extended periods.
- Ability to work effectively under pressure to meet deadlines.
- Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening.
- Must be able to lift 50 lbs.
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.