
Scientific Expert
1 week ago
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.
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