CONCORD BIOTECH Hiring for Regulatory Affairs Department

  • Full Time
  • Gujarat

CONCORD BIOTECH

CONCORD BIOTECH (Biotech for Mankind…)

WE ARE HIRING!

DEPARTMENT: REGULATORY AFFAIRS

Experience: 08 to 15 years in Regulatory Affairs

Designation: Deputy Manager / Manager / Sr. Manager

Responsible for:

•Working for US, EU, Brazil, Japan, Russia, Korea & Row Market

• Preparing Dossiers for registration of products in various markets

DMF Preparation, review and submission according to latest requirements

• Knowledge in regulatory affairs, eCTD and regulatory guidance.

• Filing of amendments & Lifecycle management as per requirement • Co-ordination with cross functional departments for documents required for regulatory submission

Post approval changes and its filing & deficiency responses to various regulatory authorities

• Good understanding of existing and emerging regulations, standards and guidance documents

• Review, compilation and submission of new marketing authorization application

• Good knowledge of Review of pharmaceutical development reports for regulatory submissions, DMF from API supplier for regulatory submission.

Location: Unit-3, API Plant – Limbasi (Dist Kheda), Gujarat.

Interested candidates can share profile on hrcbl@concordbiotech.com

Contact 02694-351600

CONCORD BIOTECH Hiring for Regulatory Affairs Department
CONCORD BIOTECH Hiring for Regulatory Affairs Department

To apply for this job email your details to hrcbl@concordbiotech.com

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