Job Title: Regulatory Affairs Specialist
This position is responsible for ensuring compliance with regulatory requirements and industry standards in the laboratory.
Job Description:
The Regulatory Affairs Specialist plays a critical role in maintaining the quality and integrity of our analytical methods and data. This involves reviewing and implementing changes to methods, specifications, and documentation to ensure compliance with regulatory requirements.
* Manage transfer/verification/validation protocols and reports for new methods
* Evaluate method clients and identify potential issues
* Perform or support feasibility experimental work as needed
* Review analytical data for accuracy and completeness
* Investigate and resolve technical issues in the laboratory
* Maintain the GMP status of the laboratory and analytical methods
* Evaluate impact of compendial changes on applicable QC procedures
Responsibilities include:
* Working cross-functionally with QC support, commercial teams, QA, IT, and other departments to introduce new technologies
* Communicating effectively with management regarding complex issues
* Trains QC personnel on new methods and procedures
Qualifications:
To be successful in this role, you will need:
* A Master or PhD degree in Life Sciences, Chemistry, Pharmacy, or equivalent
* 5 years of work experience in a GMP environment (pharmaceutical industry)
You will also need:
* Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements
* Thorough knowledge of quality systems and deviations handling
* Structured and analytical approach to problem solving
* Excellent scientific knowledge and hands-on experience of chromatography techniques, dissolution, UV, and IR techniques
* Experience of analytical testing according to Ph. Eur., JP, and USP requirements
* Advanced knowledge of analytical method transfers and analytical method validation/verification
* Advanced GMP documentation skills and technical writing skills
* Experience in laboratory equipment qualification and software qualification
* Advanced knowledge of Data Integrity principles and audit trail review requirements
Benefits:
We offer a competitive salary and benefits package, including:
* Opportunities for professional growth and development
* A collaborative and dynamic work environment