Alpha-Pharma is an export oriented generic company incorporated in late 2005. We opened our office in India in 2006 from where we have build our current organization. As a company we are open minded and always open to new opportunities and possibilities. We encourage an open dialog with our employees which continuously brings new aspects and considerations to our organization.
Post: Regulatory Affairs Specialist/Manager - Regulated Territories
Job Description:
Alpha-Pharma Healthcare seeks a senior Regulatory Affairs Specialist with experience within Pharmaceutical Development, regulatory Quality documentation and generic formulation applications for medicinal products for the EU market.
The candidate will be in-charge for development of Common Technical Dossiers (CTD's) for the European marked as well as management of develoment team.
Candidate Profile:
We expect that you have experience with EU regulatory and scientific requirements and experience with strategic planning of studies needed for the preparation of CTD dossiers. In depth knowledge with EU quality requirements is necessary.
We further expect that you have a minimum of 15 years experience in drug regulatory affaris, and has previously worked with development of the European CTD formats for generic molecules Preferably you have been in-charge of team management, supervision and co-ordination.
Additional Information:
Experience: min. 15 years
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Apply/Send resume at, vacancy@alpha-pharma.com
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