Regulatory Affair Associate

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.
• Reference: qP4qy7RlhLfP-t_kL-GJVcyvCvmHZuAo8QPHP-VqsmYdC8mbDnD-Q2ONHS60PqSR

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.