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.