Job Title: Regulatory Affairs Manager
No. of Posts: 4
Salary: INR 50,000 – 3,00,000 P.A.
I. Associate, Regulatory Affairs Europe, Middle East & Africa (EMEA)
The Apotex EMEA Regulatory Affairs team is responsible for the operations and management of regulatory activities pertaining to new medicinal products (New Product Development: NPD) from In-house or 3rd party sources and Out licensing (OL), as well as those already registered (Product Life Cycle Management: PLCM) in the countries of the European Economic Area, full geographical Europe, MiddleEast & Africa.
a. M. Parma/MSc. with 4-5 years of experience with PLCM for Europe in the pharmaceutical industry.
b. Assist in preparation, co-ordination and timely implementation of regulatory activities in support of PLCM submissions and other operational and cross functional activities for the selected products and markets across Europe. Conduct the peer review of pre-compiled e-CTD PLCM dossiers before final dispatch to EU RHQ.
c. Experience with Track-Wise, Lorenz Docubridge e-CTD system is a plus.
II Associate/Sr. Associate Global Regulatory Affairs Labelling
Responsible for compilation and submission of labelling dossiers for registration of Apotex products in identified markets and the creation, review and approval of commercial labelling. Also responsible for providing support to a team of RA Associates in the completion of labelling projects supporting regulatory submissions and label commercialization.
a. BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences. Diploma from a RA program would be an asset.
b. Responsible for the preparation and peer review of quality regulatory labelling submissions for various markets to ensure timely approval
c. Responsible for the maintenance and timely completion of regulatory labelling documents to support regulatory compliance in various markets.
d. Responsible for the creation, review and approval of commercial labelling for various markets and private label customers.
III Associate/Sr.Associate – Global Regulatory Affairs PLCM
Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets. Also responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.
a. B. Pharma/M. Pharma/MSc. with 4-7years of experience with drug development and drug submissions for US/Canada markets.
b. Approval of change control documents and quality notifications as assigned
c. Responsible for the preparation and peer review of quality regulatory submissions for various markets to ensure timely approval
d. Works with other functional areas to resolve issues related to information for regulatory submissions.