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Senior Executive Regulatory Affairs @ Aizant

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 Senior Executive Regulatory Affairs

Job Description

Roles and Responsibilities

  • Responsible for preparation and compilation of the dossiers in CTD/eCTD and other formats as required for submission to different regulatory authorities.
  • Review the documents i.e Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc.
  • Preparation of query response for submitted applications received from various regulatory authorities.
  • Responsible for life-cycle management of regulatory submissions.
  • Responsible for preparation and maintenance of all the documents related to the regulatory submissions.
  • Coordinate and supports all concerned departments with respect to the required documents for submission purpose.
  • Responsible for review of change controls and checking for regulatory compliance for all documents.

Training the line function in updating the current guidelines and requirements.


Interested candidates can share their updated CVs to ca****s@ai***t.com with subject line as

Regulatory affairs US market


Only the profiles matching the above job description criteria will be scheduled for Telephonic /Personal Interview


*Candidates from formulation division will be considered.


,

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Sales / BD
Functional Area: Not Applicable
Role/Responsibilies: Senior Executive Regulatory Affairs

Contact Details:

Company: Aizant
Location(s): Hyderabad

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₹ 5 - 12 Lakh/Yr

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Aizant

Company ProfileAizant Drug Research Solutions Pvt. Ltd.Aizant is an integrated drug development solutions provider. Aizant was established by experienced pharmaceutical professionals with global exposure.We are a rapidly growing formulation CDMO and CRO with a diverse portfolio of capabilities par...