Pharmaceutical Regulatory Expert

Job SummaryWe are looking for an experienced Regulatory Affairs Manager to oversee the preparation and review of various modules of ANDAs, NDAs, and responses to FDA queries.The ideal candidate will have in-depth knowledge of regulatory CMC documents and approval processes, as well as experience with e-CTD compilation.This role involves providing regulatory...

**Job Description:**We are looking for an experienced Pharmaceutical Analytical Expert to join our team at Ingenus Pharmaceuticals. As a key member of our R&D department, you will be responsible for developing and validating analytical methods, conducting stability studies, and collaborating with cross-functional teams to drive innovation in pharmaceutical...

Job Title:Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ingenus Pharmaceuticals. The ideal candidate will have 8+ years of experience in regulatory strategy and filing of ANDAs, New Drug Applications (NDA) in a pharmaceutical industry.This role requires hands-on experience of...

Key ResponsibilitiesThe Pharmaceutical Method Developer will be responsible for designing, developing, and validating analytical methods to support the development and manufacture of pharmaceutical products. This includes method development, method validation, and method transfer activities. The successful candidate will have a strong understanding of...

Job DescriptionIngenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum.We are seeking an experienced Chemical Development Expert to join our analytical team. The successful candidate will have a strong background in...

**About the Role:**We are seeking a highly skilled Senior Scientist to join our team at Ingenus Pharmaceuticals. This is an exceptional opportunity for an experienced analytical chemist to lead and develop advanced methods, collaborate with cross-functional teams, and drive innovation in pharmaceutical development.The ideal candidate will have a strong...

**Laboratory Manager Job Summary:**We are seeking a highly motivated and experienced Laboratory Manager to join our team at Ingenus Pharmaceuticals. In this role, you will be responsible for leading a team of analysts, developing and implementing laboratory policies and procedures, and ensuring compliance with regulatory requirements.The ideal candidate will...

Job DescriptionJob Description· Prepare and review various modules of ANDAs, NDAs, and responses to FDA queries.· Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for NDA’s.· In-depth knowledge and experience of regulatory CMC documents review, and approval is required.· Provide regulatory guidance to...