Regulatory Affairs Executive

2 days ago

Vadodara, Gujarat, India Amico Formulations LLP Full time ₹ 2,50,000 - ₹ 3,00,000 per year

POST: RA OFFICER/EXECUITVE

LOCATION: JAROD, VADODARA

EXPERIENCE: 2-3 YEARS

Experience in handling regulatory affairs for ROW market mainly Latin American, African & Asian countries for Pharma Formulations.

Preparation, compilation & Review of Registration documents that include Administrative & Technical.

Reviewing the technical documents provided by QA, QC, Production Providing them the report of shortcomings & ensures them to correct the documents.

Handling RFIs (Requested Further Informations) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data.

Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation.

Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies.

Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames.

Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner.

Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team.

Fill up customer questionnaires by collecting information from various concerned departments.

You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.

Maintenance of the complete history of each drug product

Job Type: Full-time

Pay: ₹250, ₹300,000.00 per year

Benefits:

  • Provident Fund

Ability to commute/relocate:

  • Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

  • Total: 2 years (Preferred)

Work Location: In person

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