Chemistry Expert - Pharmaceutical Industry
In our pursuit of excellence, we seek a highly skilled Chemistry expert to contribute to the development and commercialization of high-quality generic medicines. This is an exceptional opportunity to join a dynamic team in the pharmaceutical sector.
About the Role
We are looking for a detail-oriented professional with experience in preparing and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions. The ideal candidate will possess strong communication skills, attention to detail, and a passion for quality.
Key Responsibilities
* Develop and review CMC documents for regulatory submissions, ensuring accuracy and compliance
* Collaborate with cross-functional teams to gather and summarize technical data
* Ensure all CMC documentation meets regulatory guidelines and company standards
* Communicate effectively with internal teams and external stakeholders
* Advise on strategy in the development and drive implementation of CMC strategies
* Contribute to continuous process improvements in CMC documentation
Required Skills and Qualifications
* Minimum 2-3 years of experience in CMC writing
* University degree in sciences
* Strong understanding of CMC documentation requirements
* Excellent written and verbal communication skills
* Detail-oriented with a focus on accuracy and regulatory compliance
* Motivated, proactive, and capable of working independently and as part of a team
* Ability to manage multiple projects and meet tight deadlines in a fast-paced environment
* Knowledge of regulatory guidelines specific to generics and the submission process is a plus
Benefits
* A dynamic work environment with opportunities to grow within a leading global pharmaceutical company
* Competitive salary and benefits package
* Exposure to exciting and impactful projects