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Poslovi.Infostud.com
Lundbeck Export A/S Predstavništvo Beograd
Lundbeck
is Danish pharmaceutical company specialised in research, development, sales
and marketing of products used for treatment of psychiatric and neurological
disorders. We are searching for proactive, highly organized and qualified
candidate willing to become part of a successful team for the position of:
Regulatory Affairs Associate
Necessary
requirements for this position are:
- University
degree in Medicine or Pharmacy
- At
least 2 years of experience in regulatory affairs
- Fluent
in English
- Computer
literacy
- Clean
driving licence (B category)
- Residence
in Belgrade.
Main
responsibilities:
- Preparing
application documentation for regulatory approval for new medicinal products,
renewals and variations;
- Improving
knowledge about regulatory legislation and being informed about changes in
regulatory environment through close communication with National Drug Agency;
- Working
on preparation of local SPC and PIL in order to ensure their accuracy from
medical, regulatory and technical point of view;
- Calculation
of prices and submission of documentation in accordance to local legislation
and corporate procedures;
- Preparation
and submission of documentation for reimbursement of medicinal products in
accordance to local legislation and corporate procedures;
- Logistic
coordination between manufacturer and local wholesalers (planning, deliveries,
sales monitoring);
- Maintenance
of local pharmacovigilance system in accordance to local legislation and
corporate procedures.
Candidates
profile:
- Well
structured personality, able to work under pressure and with tight deadlines;
- Strong
organizational skills with attention to details;
- High
degree of initiative with excellent planning skills.
Please
send your application letter and Curriculum Vitae in Serbian (Latin) and
English to the e-mail
{mail}
with subject "Regulatory Affairs Associate"
or
via regular post to our address:
Lundbeck
Export A/S Predstavništvo Beograd
Bulevar
Zorana Đinđića 48a
11070
Beograd
The deadline
for receiving applications is 25.10.2008.
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