Regulatory Affairs Officer/Execitive

  • icon job experience 2 - 8 Years
  • icon job opening 4 Openings
  • icon salary Not Disclosed
  • icon job location Mumbai
  • Face-to-Face interview Face-to-Face interview

Job Description

Roles and Responsibilities :

Regulatory/ DMF

Asking for necessary technical inputs from various departments in the Factories and doing its assessment.

To give the necessary technical inputs required by the respective government departments (FDA, CDSCO ) under the guidance of the Head Regulatory

Compilation, review and submission of DMF (Drug master file) to Regulatory & ROW markets as per the given guidelines.

To keep DMF files active as per the agency requirements.

Revision/Renewal of CEP.

Compilation & submission of Applicants part DMF (Drug master file) & QOS for customers.

Compilation & Submission of RP DMF for authorities.

Submissions of DMF Annual report to USFDA

Submissions of DMF amendments to USFDA

Reply to the queries raised by respective authorities

Customer Servicing

Responsible to address different questions and queries (technical) in the given time frame for customers

To get the necessary information from QA, QC for compilation and onward submission to regulatory authorities and customers as response to their queries

To evaluate the technical agreements /CDA to be signed with the customers as on basis.

Review of vendor questionnaire within the required timeframe along with supporting documents to customers and maintaining the record for the same.

Preparation of the certificate of suitability for various customers

Preparation/review of different kinds of declarations as per customer requirements

Review of change control, customer notification/intimation

Keeping the track of customer notification/Intimation and response to the various queries raised by various customers & Log Maintenance

Preparation of LOAs
  • Experience

    2 - 8 Years

  • No. of Openings

    4

  • Education

    Diploma, Professional Degree, Any Bachelor Degree, B.Pharma, Post Graduate Diploma, M.Pharma

  • Role

    Regulatory Affairs Officer

  • Industry Type

    Pharma / BioTech / Clinical Research

  • Gender

    [ Male / Female ]

  • Job Country

    India

  • Type of Job

    Full Time

  • Work Location Type

    Work from Office

About RBM Placement

We are a leading placement consultant (RBM Placement Solution) Managed by Doneasy Services Pvt. Ltd. having 2 offices in Maharashtra. We have been operating since Jan 2018, Registered and are looking forward for a professional tie-up with your esteemed organization for manpower requirements.rnWe are confident that we can provide you the best people in the industry for various locations in whole India as we have got a strong database of job-seekers. We help over 25+ customers especially Pharmaceutical(API/Formulation)/Chemical companies in last few Months of existence, in hiring best talents.
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