Asst Manager / Deputy Manager, Formulation & Development Injectable Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

Role Overview: You will be responsible for product development activities of all injectable dosage forms for regulated markets including General injectable, Onco, and Peptide products. You will need to have a good understanding of ANDA and 505b2 product filing, as well as exposure to a wide range of dosage forms such as liquid solution, lyophilized, and suspension. Your role will also involve understanding Drug device combination products and regulatory expectations. You will be experienced in preparing and reviewing product development reports, MFR, stability protocols, study protocols, SOPs, and have a basic understanding of implementing QbD principles for formulation development. Key Resp...

Posted 1 week ago

AI Match Score

Apply

Regulatory Affairs Associate I, Labeling Teva Pharmaceuticals

1.0 - 5.0 years

0 Lacs

navi mumbai, maharashtra

On-site

Role Overview: As a RA Associate I at the company, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations and meet deadlines to align with company goals. Your role will involve developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring alignment with company goals and submission requirements while meeting all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents. - Establish SPL for assig...

Posted 3 weeks ago

AI Match Score

Apply

Deputy Manager - Pharmacokinetic Modelling and Simulation Scientist Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as Win...

Posted 1 month ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.