CMC Specialist – FDA Compliance

Regulatory Affairs Specialist: CMC AssociateWe are seeking a highly skilled Regulatory Affairs Specialist to support US FDA submissions and lifecycle management activities.Main Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

As a Regulatory Affairs CMC Associate, you will play a key role in supporting US FDA submissions and lifecycle management activities. This dynamic position offers the opportunity to enhance your career while working collaboratively as part of a dedicated team.Key Responsibilities:Prepare and Review Regulatory SubmissionsMaintain Compliance with US FDA...

Job Description – Regulatory Affairs CMC Associate (US Market) We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities. Key Responsibilities: Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format....

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or...

Job Summary:We seek an accomplished Regulatory Affairs Specialist to serve as Assistant Manager / Manager Regulatory Affairs – Complex Products.The ideal candidate will possess a minimum of 10+ years' experience in the pharmaceutical industry with expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU markets.Preparation and...

Job Summary:We are seeking a highly skilled Regulatory Affairs Associate to join our team.The successful candidate will have a strong understanding of US FDA regulations and ICH guidelines, with 4+ years of experience in handling pre- and post-approval submissions.This is an excellent opportunity for individuals who are passionate about regulatory affairs...

Job OverviewWe are seeking a skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for ensuring the technical congruency and regulatory compliance of our products in the US market.Main Responsibilities:Develop high-quality CMC documentation for US FDA submissions in accordance with latest guidances.Identify required...

About This RoleThis Regulatory Affairs position is focused on the development and execution of regulatory strategies for complex products.The incumbent will be responsible for ensuring compliance with regulatory requirements across multiple markets, including the US, Europe, and UK.Specifically, this role involves:Regulatory Compliance: Ensuring adherence to...

Regulatory Affairs - Career OpportunityWe are seeking a skilled Regulatory Affairs Associate to join our team. As a key member of the Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guiding the company through the complex process of obtaining necessary approvals.&## ; Years of Experience:4+...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...