Amoli Organics Recruiting For Asst. Manager / Dy. Manager / Manager – Regulatory Affairs (RA) .100 strong dedicated work force. , 2 state-of the art manufacturing Sites , Sites are CGMP and SHE compliant. USFDA, ANVISA, EDQM, COFEPRIS- Cleared Presence in USA, EUROPE, JAPAN, RUSSIA, SOUTH EAST ASIA, MIDDLE EAST AND LATAM. Amoli has a successful track record in the pharmaceutical and allied industry. Making a beginning as a manufacturer of API”s and Intermediates, it made successful forays in the field of “Contract Research” and “Custom Synthesis”. Amoli has been working collaboratively with some of the leading global healthcare players.
Eligibility and other details :
- Post Name: Asst. Manager / Dy. Manager / Manager – Regulatory Affairs (RA)
- Qualification: B.Pharma,M.Pharma with 08-12 Years of Experience
- Location: Vadodara
- Salary: Not Disclosed
- No Vacancies: 02
- Selection Process : Based on Resume Received,will shortlist.
Job description:
- Ensuring preparation and timely submission of high-quality documents to various Regulatory Health Authorities (USFDA, EDQM, PMDA, CFDA, Health Canada, Taiwan FDA, ANVISA, KFDA etc.,) in CTD/eCTD formats Applying regulatory strategies, assuring compliance, meeting agreed timelines and submit to health authorities throughout project lifecycle. Prepare deficiency responses to health authority during product lifecycle. Preparation and submissions of amendments, annual reports, revisions, renewals etc. in respective markets for life cycle management. Identify the documents required for global submissions from respective departments Evaluate vendor documents for adequacy as per regulatory requirement. Evaluate carryover study/ spike-purge study, as applicable and provide required guidance and support to R&D / ADL Coordination with various departments like R&D, ADL, Purchase, QC, QA & Production etc., follow up and keep a track to ensure timely availability of documents and/or for the content, quality related issues, or any other issues that may impact submission quality or timelines.
