13 Fda Approval Jobs

As a Regulatory Affairs Director at Azurity Pharmaceuticals, your role involves ensuring the development and implementation of effective regulatory strategies for projects in development and approved. You will be responsible for providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, as well as leading the execution of regulatory strategies for pre-approval and post-approval activities. Your oversight of regulatory team activities will include managing filings, conducting technical reviews of documents, and ensuring regulatory compliance. - Develop and implement robust regulatory strategies and plans for projects, ensuring regula...

As a Production Manager, you will need to hold a degree in B.Sc/M.Sc/B.Pharm/M.Pharm with FDA approval in topical preparations. With a CTC of 7 to 8 lac per year, you will be required to work in 8-hour shifts and possess at least 10 to 15 years of experience in topicals. Your responsibilities will include: - Production planning based on clients" purchase orders and ensuring its successful implementation. - Verifying dispensed raw materials, maintaining and updating the Production Module on the PERP system. - Overseeing the manufacturing of cream, ointment, and lotion. - Executing instructions related to production operations and in-process control. Furthermore, your duties will involve: - On...

Job Description You will be responsible for overseeing the regulatory affairs of the company, ensuring compliance with FDA regulations. Your role will involve working closely with cross-functional teams to achieve regulatory approvals for new products and maintain existing approvals. Key Responsibilities - Develop and implement regulatory strategies for new product submissions - Prepare and submit regulatory documents to the FDA - Coordinate with internal teams to ensure compliance with regulations - Stay updated on changes in FDA regulations and communicate implications to the team - Participate in regulatory agency inspections and audits Qualifications Required - Bachelor's degree in Scien...

The job requires 2-3 years of work experience and a qualification of Bsc Micro/Msc. Micro + DMLT. The responsibilities include performing tests effectively and interpreting correctly in all sections of the Blood Bank as and when required. FDA Approval would be an added advantage. The position is located at Kiran Hospital with a total of 8 positions available.,

As a Quality Control Microbiologist at our company located in Solapur, Maharashtra, you will be an integral part of the Quality Control Microbiology department. Having FDA approval is an essential requirement for this role. With a minimum of 4 years of experience, you will be responsible for ensuring the quality of our products meets the required standards. We are currently looking to fill one position for this role on a full-time, permanent basis. The ideal candidate should have at least 1 year of total work experience, although this is preferred and not mandatory. The work location for this position is in person. If you meet the experience criteria and have the necessary qualifications, pl...

You are seeking an experienced and highly skilled Quality Control (QC) Manager to lead the QC team at Inducare Pharmaceutical & Research Foundation in Jejuri, Pune. As the Quality Control Manager, you will be responsible for overseeing all QC operations, ensuring compliance with regulatory standards, and driving continuous improvement in processes. The ideal candidate should have a minimum of 12 years of QC experience, with at least 5 years in a managerial role. Your key responsibilities will include leading and mentoring the QC team, managing team performance, and providing training and development opportunities. You will oversee all QC activities, including testing of raw materials, in-pro...

Should have background of Sterile Formulation /Ophthalmic products Managerial level experience required 10+ years

To lead and manage sterile pharmaceutical manufacturing operations (Ophthalmic / Injectables), ensuring adherence to cGMP, regulatory guidelines, safety standards, and production targets while maintaining high product quality and cost efficiency. Required Candidate profile B. Pharm / M. Pharm / B.sc /M.Sc 15–20 years of strong experience in sterile/injectable manufacturing with at least 10+ years managerial role

The ideal candidate for this position will have a mission to make good health more affordable and accessible, helping millions around the world enjoy healthier lives. Working with the leading manufacturer of generic medicines, you will be a part of a team that produces products listed on the World Health Organizations Essential Medicines List. With at least 200 million people worldwide taking our medicines daily, we are continuously striving to make a positive impact and are looking for individuals to join us in this mission. Your responsibilities will include conducting Microbiological testing on various products, such as in-process, finished products, pre-formulation study samples, and sta...

As a potential candidate for this role, you should have a Bachelor of Pharmacy degree with FDA approval in Liquid Oral products. With 5 to 8 years of experience in the pharmaceutical industry, you will be expected to bring expertise and knowledge in this field. Your qualifications and experience will be crucial in ensuring the successful execution of duties related to pharmaceutical products, particularly in the domain of Liquid Oral medications.,

As a Production Manager, you will be required to have a B.Sc./M.Sc./B.Pharm/M.Pharm qualification with FDA approval in topical preparations. With a CTC of 7 to 8 lac per year, you will be expected to work in 8-hour shifts and possess 10 to 15 years of experience in topicals. Your primary responsibilities will include production planning in accordance with clients" purchase orders and ensuring its successful execution. You will be accountable for verifying the dispense of raw materials, maintaining and updating the Production Module on the PERP system, and overseeing the manufacturing of cream, ointment, and lotion. Moreover, you will be responsible for implementing production operation instr...

As a Production Manager, you will need to hold a degree in B.Sc/M.Sc/B.Pharm/M.Pharm with FDA approval in topical preparations. With a CTC of 7 to 8 lac per year, you will be required to work in 8-hour shifts and possess at least 10 to 15 years of experience in topicals. Your responsibilities will include production planning based on clients" purchase orders and ensuring its successful implementation. You will be responsible for verifying dispensed raw materials, maintaining and updating the Production Module on the PERP system, and overseeing the manufacturing of cream, ointment, and lotion. It will be crucial for you to execute instructions related to production operations and in-process c...

Responsibilities: * Ensure compliance with regulatory standards * Conduct chemical testing and method validation * Collaborate with R&D team on product development * Manage quality control processes from start to finish