Executive / Senior Executive - Regulatory Affairs
6 Nos.
98414
Full Time
3.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
Production / Quality / Maintenance
Job Description:
DMF API Submission experience is must
- Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements.
- Preparation of Applicant part of DMF for Brazil, US, and ROW market.
- Preparation of all administrative statements for respective authority requirements.
- Drafting of regulatory response for deficiencies received from regulatory authorities as well as for customers queries.
- eCTD publishing for DMF to respective Authority.
- Adequately review of vendors documents of key starting material/Raw materials/ intermediates of API as per regulatory requirements.
- Review of documents like AMV, PDR, TTD, characterisation report and support to R&D team during API development.
- Preparation of Change Notification to customers.
- Review and maintenance of change control compliance data for regulatory filing in respective markets.
- To coordinate with CFTs like R&D, QA, QC, ADL, and production to get supporting documents as per filing requirements
Company Profile
--- --- is an independent --- driven company specialized in the custom synthesis of pharmacopeial & non-pharmacopeial reference standards, drug glucuronides, drug metabolites, Isotope labelled reference standards and focused compound libraries. As a ----driven organization, we have developed novel processes to make niche products required to pharmaceutical companies globally at various platform. We understand the industry --- needs thoroughly and have earned reputation for being most reliable innovator of pharmaceutical reference standards worldwide.
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- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.