Meyer Organics is hiring For Regulatory Affair Executive/Stores Executive.We think harder to make healthcare simple Welcome to MEYER Organics – India’s one of the leading pharmaceutical manufacturer, founded in 1982 in technical collaboration with OMEGA – MEYER Ltd., Jersey ( Br. Isles).Interested and eligible candidates can share resume at firstname.lastname@example.org
Vacancy Details :
- Company Name: Meyer Organics
- Location : Thane
- Post Name: Regulatory Affair Executive/Stores Executive
- Qualification: B.Pharmacy
- Experience: 3 – 5 years
- No of Vacancies: NA
- Details of Salary: 3,00,000 – 6,00,000 P.A.
- Contact: email@example.comfirstname.lastname@example.org
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
Hiring For Regulatory Affair Executive/Stores Executive in Meyer Organics Pvt. Ltd! If interested candidates can share your resume to mentioned mail ID
Regulatory Affair Executive
1. Manage timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Export products registration/renewal/variation for drug/ food/ other commodities items
2. Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory bodies of various countries
3. Preparing, submitting, reviewing regulatory file applications and supporting documentation with all registration related tasks post approval authorization, queries, post approval authorization-variations, renewals, fees (Pharmaceutical, Nutraceutical & Herbal)
4. Prepare dossiers for ROW, MENA, CIS and South-East countries as per requirement
5. Developing regulatory strategies for new products and vendors (third party manufacturing)
6. Advice and counsel to cross-functional teams including Packaging, QA, QC, R&D and production team.
7. Reviewing Artwork & PIL
8. Responding to agency deficiency requests within strict timelines
9. Contributing to the planning, execution, and assessment of product life cycle management activities and strategies
10. Contributing to developing CMO
11. New Product Development
12. Responsible for lifecycle maintenance of DMF (Drug Master File), SMF (Site Master File) and Method Validation.
13. Any other responsibility assigned by the technical head.
1. Dispensing of Raw Material/Packing Material.
2. Raw & Packing Materials Planning (Procurement) as per Export order & Domestic Plan.
3. Raw material receiving as per our Approved Vendor List.
4. GRN preparing & intimate to Q.C. Dept.
5. Daily Balance calibration of Weighing Balances & Daily Records required for Stores.
6. Preparing Monthly Retesting, Non- Moving Report & Stock Statement Report
7. Follow up with Purchase Dept. & Q.C. Dept.
8. Finished Goods Transfer to depot or other plants & documents required for same. (Vehicle Arrangement, Rate of Product Challan preparation & E-way Bill).
9. Finished goods Monthly Statement for account Dept.
10. Material transfer to Loan licensee site Challan, Tax Invoice & E-way Bill.
11. MIS Report.