Job for Executive/Sr. Executive –Regulatory Affairs at Panacea Biotec | M.Pharm, M.Sc
Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. 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.
Post: Executive/Sr. Executive –Regulatory Affairs
- Working for the post approval life cycle management of approved ANDAs US / 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
Experience: 3-6 years
Age: 25-35 Years
Location: Navi Mumbai
Industry Type: Pharma/Biotech/Vaccines
Compensation: As per Industry Norm
Functional Area: Regulatory Affairs
Last Date: 15th July, 2017
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