Pharma Job : Regulatory Affairs Manager Post @ Apotex Research

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Apotex Research Pvt. Ltd.
Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 10,000 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies has over 6,000 employees. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe.

Job Title  Regulatory Affairs Manager

No. of Posts 4

Salary:  INR 50,000 – 3,00,000 P.A.

Qualifications

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, Middle

East & 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.

Apply Online

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