Regulatory Affairs-CMC

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 DescriptionThis Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance's and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.Our...

One of our client based at Mumbai (Reputed MNC Company) is looking for below positionsRole & responsibilities1. Asst Manager / Manager/Sr. Manager - Biologics Regulatory Affairs (Clinical Trials)-2 positionsJob Location: Govandi (East ), Mumbai (alternate Saturday working)Desired Qualification: M.Pharm/B.PharmDesired Work Experience: 5-10 yearsJob...

Designation:Regulatory affairs -Executive/ Sr. ExecutiveJob Location:MumbaiJob Summary:The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR...

USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.Explore us at Function: BiologicsPosition: Deputy Manager/Manager - Regulatory Affairs-CMCJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd...

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure...

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...

REQUIRE EXPERIENCE IN MODULE 1 COORDINATION AND SUBMISSIONS.MAIN PURPOSE OF ROLEExperienced professional individual contributor that works under limited supervision.Applies subject matter knowledge in the area of Regulatory Affairs.Requires capacity to apply skills/knowledge within the context of specific needs or requirements.MAIN RESPONSIBILITIESAs the...

Job Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...