EXPERIENCE: 5+ YEAR IN REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY
QUALIFICATIONS : B.PHARM/M.PHARM
JOB DESCRIPTION:
- Compiling & documentation of wide range of data and information of Regulatory Affairs.
- Knowledge of regulatory guidelines of various countries.
- Information of regulatory compliances, knowledge of various ICH guidelines and cGMP guidelines.
- Ensuring preparation of documentation according to the requirements of MOH of the concerned country for various dosage form.
- Monitoring and checking of registration and re-registration dossiers of formulations & EHGC.
- Sorting out technical queries received from agents and health authorities of
- respective countries for registration of products.
- Co-ordination with Quality Assurance, Quality Control, R&D, packing,
- Production for technical data from different manufacture.
- Checking for artwork development of packing material for product.
- Maintain the registration certificate and maintain the records of registered
- products for renewal of registration.
- Upgrading knowledge in line with ever changing regulatory requirements.
- Compilation of documents for company registration and inspection by
- overseas regulatory authorities.
- Furnishing the scientific responses to deficiency queries received from
- various regulatory bodies.
- Application of Manufacturing Licenses for new products and COPP
- Review of BMR, PDR, Process Validation Data, Validation of Analytical
- Procedure, stability data, dissolution data, specifications etc.
- Checking of Artwork as per the guidelines
- Have acquaintance with CTD filling to various regulatory bodies.
- Co-ordinate with various departments lime QA, QC, Production, F&D,
- Artwork development department for collecting and processing various
- technical documents required for dossier compilation.
- Coordinate with Third parties for procuring the documents required for
- registration as per the requirement.
- Compilation of dossier for Formulations
- Responsible for notarization and legalization of administrative documents
- , from Embassy as per country requirement.
- Document preparation for FDCA application like Product Permission, Free
- Sale Certificate, Certificate Of Pharmaceutical Products with or without WHO
- inclusion, Loan License Manufacturing application, GMP Certificate
- application, WHO GMP Certificate application, Product inclusion in WHOGMP
- list, Supervisory Chemist for LLM, Test License application, Product
- Permission with NOC, Non Standard Quality Certificate application, Query
- certificate for relevant country guideline as well as customer requirement.
- Control of online doc mentation according to FDCA reguirement and
- Freezing process.
- Good knowledge of Drugs and Cosmetics Acts.
Job Type: Full-time
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
Benefits:
- Provident Fund
Schedule:
- Day shift
Experience:
- total work: 1 year (Preferred)
Job Types: Full-time, Permanent
Pay: ₹30,000.00 - ₹40,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Schedule:
- Day shift
Work Location: In person
Job Types: Full-time, Permanent
Pay: ₹35,000.00 - ₹48,679.31 per month
Benefits:
- Cell phone reimbursement
- Health insurance
- Provident Fund
Schedule:
- Day shift
Work Location: In person
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