Home / Jobs / Panacea Biotec Hiring for Executive Position | Pharma Candidates Eligible

Panacea Biotec Hiring for Executive Position | Pharma Candidates Eligible

Panacea Biotec is a leading research based Health Management Company. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.

We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Job Title – Sr. Executive / Executive – Regulatory Affairs

Experience – 3 to 6 years

Age –  25-35

Location –  Mumbai Grand R&D

Compensation –  As per the Industry

Qualifications – MPharm

Desired Profile

  • Working for the post approval life cycle management of approved ANDAs / EU Dossiers and data compilation and coordination with internal and external stakeholders.
  • Dossier compilation in CTD format for submission to ICH region(US,EU & Canada) and other regions such as Australia, New Zealand etc for solid orals dosage forms.
  • Document compliance of different dossier documents for adequacy and accuracy. It includes mainly CMC Documents, Vendor document, Pharmacokinetics study protocols and reports.
  • Well verse with eCTD and SPL (Structured product labeling).
  • Coordination with all involved parties in a product life cycle in product development , dossier compilation, query phase and post approval changes.
  • Management of dossier data and updating scientific information within organization in the field of regulatory.
  • Impact analysis on submitted dossiers during assessment phase due to change in regulations or requirements.
  • Liasoning with project management team for maintaining timelines for dossier submission.
  • Dossier document review, correction, adequacy and accuracy check.
  • Coordination with other internal and external parties in dossier /query compilation stage.
  • Should have understanding of review of open part of DMF’s/CEP Package/Technical Package.
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About Diluxi Arya

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