Job Title: Chemistry Specialist
About the Role:
We are seeking a skilled professional to support our global submissions by contributing to the development of information management expertise and country-specific knowledge.
Key Responsibilities:
* Contribute to the global submission strategy by developing appropriate information management expertise and country-specific knowledge.
* Coordinate global registration activities, request, and provide necessary documentation to affiliates for product registration in global countries.
* Prepare and request Certificates of Analysis, FDA Certificates of Pharmaceutical Product, GMP Certificates, monographs, Disclaimers, Regulatory Letters, and Declarations.
* Oversee and manage activities to register new products and renew existing products in global markets.
* Support Document Finalization Testing (DFT) for assigned products.
Requirements:
* Bachelor's Degree in a scientific or health sciences discipline, such as pharmacy, chemistry, or a related field.
* Knowledge of pharmaceutical drug development or industry-related experience is preferred.
Preferred Skills:
* Drug development process or industry-related experience.
* Knowledge of Agency submission procedures and practices.
* Awareness of emerging electronic standards.
* Ability to operate in a regulated environment and manage operational requirements.
* Effective communication, interpersonal, and teamwork skills.
* Attention to detail and ability to prioritize tasks effectively.
About Us: We are a leading organization in the pharmaceutical industry, dedicated to delivering high-quality products and services. Our team is passionate about innovation and excellence, and we offer opportunities for professional growth and development.