Skip to main content

Job for Executive/Sr. Executive –Regulatory Affairs at Panacea Biotec | M.Pharm, M.Sc

Pharma courses


GPAT courses


pharma courses


pharma courses


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

Job Description
- 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


Additional Information:
Experience: 3-6 years
Age: 25-35 Years
Location: Navi Mumbai
Education: M.Pharm

Industry Type: Pharma/Biotech/Vaccines
Compensation: As per Industry Norm
Functional Area: Regulatory Affairs
Last Date: 15th July, 2017

Apply/Forward your Resume, /

See All   Panacea Jobs   M.Pharm Alerts   M.Sc Alerts   Baddi Alerts

See All   Other Jobs in our Database

PharmaTutor Magazine- Latest Issues

Subscribe to Pharmatutor Job Alerts by Email

Search this website