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Head Regulatory Affairs

15.00 to 20.00 Years   Chandigarh   21 Jun, 2022
Saurav Chemicas Limited
Job LocationChandigarh
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSBU Head / CEO / Director
EmploymentTypeFull-time

Job Description

    Company Name: - Saurav Chemicals LimitedPosition: - Head Regulatory Affairs Location Derabassi (Punjab) near to Ambala and Chandigarh COMPANY PROFILE: - SCL (Saurav Chemicals Limited) is a 25-year-old API manufacturing company with two manufacturing units located in Derabassi at five KM from each other -one for domestic supplies and another for exports. We have USFDA, EU-GMP, WHO Geneva, KFTA, PMDA and TGA, Australia certifications thereby opening the global markets. SCL believes in planet, people and profits and has a dedicated cell for CSR working on rural schools. It has doubled its profits and turnover in the last three years and is being run by a professional board of both executive and independent directors. Looking for a highly motivated and talented candidate with 11+ years of experience in the pharmaceuticals industry who has multidisciplinary experience in the field of Regulatory Affairs for API and Intermediates. The candidate must have a strength in leading teams engaged in Regulatory Affairs. KEY DELIVERABLES To guide the RA team with updated regulatory guidelines. Preparing, reviewing and submission of USDMF, EDMF/ASMF and COS/CEP Preparing, reviewing and submission of CTD Module-II and Module-III Preparation and submission of customer specific DMFs Submission of Query responses to customers & various regulatory authorities within timeframe. Amendments and Annual notifications submissions to regulatory authorities. Reviewing change control and other documents procured from QA and other departments. Preparation and submission of LOAs, LOCs etc. as per customer requirements. Preparation and submission of CMC documents for customers / Authorities PERSON PROFILE: - Age- Between 35 to 48 years Educational Qualifications: - MSC Behavioral Competencies: - Good communication skills Ability to work in team . Good presentation and analytical skills Industry: Pharmaceutical & Life Sciences Functional Area: Legal & Regulatory Role Category: Corporate AffairsRole: Head - Regulatory AffairsEmployment Type: Full Time, Permanent ,

Keyskills :
api manufacturingpreparationchange controllife sciencescontinuous improvement facilitation

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