6 Regulatory Markets Jobs

You will be responsible for preparing IP/Patent landscape and clearance reports for parenteral, ophthalmic, and solid oral products. Additionally, you will be preparing IP evaluation reports for Regulatory markets such as USA, Canada, and Latin American markets, and providing formulation suggestions to the developmental team. Your role will also involve conducting FTO/infringement analysis and assisting in preparing infringement/non-infringement strategies for all developmental projects. Furthermore, you will evaluate all API characteristics (polymorph, particle size, purity profile, etc.) for all developmental products across various dosage forms. - Prepare IP/Patent landscape and clearance...

In this role, you will be responsible for preparing IP/Patent landscape and clearance reports for parenteral, ophthalmic, and solid oral products. You will also be tasked with preparing IP evaluation reports for Regulatory markets such as USA, Canada, and Latin American markets. Additionally, you will provide formulation suggestions to the developmental team and conduct FTO/infringement analysis. Your role will involve assisting in preparing infringement/non-infringement strategies for all developmental projects. Furthermore, you will evaluate all API characteristics (polymorph, particle size, purity profile, etc.) for all developmental products across various dosage forms. Qualification Req...

As an Intellectual Property Rights professional at Caplin Point, Chennai, your role will involve the following responsibilities: - Prepare IP/Patent landscape & IP/Patent clearance reports for parenteral, ophthalmic, and solid oral products - Create IP evaluation reports for regulatory markets such as USA, Canada, and Latin America, and provide formulation suggestions to the developmental team - Conduct FTO/infringement analysis and assist in preparing infringement/non-infringement strategies for all developmental projects - Evaluate all APIs characteristics (polymorph, particle size, purity profile, etc.) for all developmental products across various dosage forms Qualifications Required: - ...

You will be responsible for formulation and process development of oral immediate-release dosage forms, Liquid Oral Dosage forms, Injectable Dosage forms including oral film and other formulations for regulatory markets such as Europe, Canada, ANIVSA, ANZ, US and others. Your role will involve troubleshooting and problem-solving unresolved or new formula issues. Additionally, you will design and execute formulation trials and evaluate stability data to finalize formulation composition. It will be your responsibility to develop manufacturing processes for R&D formulations to ensure successful technical transfer for large scale batches. You will also be accountable for all formulation/process ...

We're looking for an experienced professional to lead and drive innovative formulation strategies from development to regulatory submissions. Experience: 16-18 Years(Group Lead) Location: Hyderabad(Dulapally) Key Responsibilities: -Lead end-to-end formulation development of OSD products for regulated and semi-regulated markets -Oversee pre-formulation, technology transfer, scale-up, and exhibit batch manufacturing -Collaborate cross-functionally with QA, QC, RA, Production, and Project Management -Ensure timely completion of development milestones and regulatory documentation (CTD/ACTD) -Mentor and guide a team of formulation scientists -Strong knowledge of ICH guidelines, regulatory expecta...

We are looking for a highly skilled and experienced Formulation Development Professional with 1113 years of experience in oral solid dosage forms (OSD). Key Responsibilities: -Lead formulation development projects from R&D to commercial scale. -Design and execute formulation strategies for ANDA/CTD/ACTD submissions. -Conduct literature search, pre-formulation studies, and prototype development. -Troubleshoot formulation and process-related challenges. -Work closely with cross-functional teams Regulatory, ARD, QA, QC, and Manufacturing. -Prepare technical documents, development reports, and support dossier preparation. -Manage technology transfer and scale-up activities to manufacturing units...