• Par­ti­cip­a­tion in the de­vel­op­ment of the reg­u­lat­ory strategy with the sub­sequent ap­plic­a­tion for ap­prov­al of the product port­fo­lio in the CIS re­gion in­clud­ing its coun­tries in the EAEU (Rus­sia, Be­larus, Kaza­kh­stan, Ar­menia and Kyrgyz­stan), Ukraine and oth­er coun­tries
• All tasks re­lated to mar­ket­ing au­thor­iz­a­tion main­ten­ance (Re­new­al, Vari­ations, Change Con­trol) for the product port­fo­lio
• Co­ordin­a­tion of dossier up­dates in close co­oper­a­tion with the Dossier- and CMC-man­age­ment
• Com­mu­nic­a­tion with reg­u­lat­ory au­thor­it­ies
• Fol­low-up, eval­u­ation and im­ple­ment­a­tion of new reg­u­lat­ory re­quire­ments in close co­oper­a­tion with Mar­ket­ing, Sales and Re­search & De­vel­op­ment
• Com­mu­nic­a­tion and co­ordin­a­tion of reg­u­lat­ory activ­it­ies in close co­oper­a­tion with Mar­ket­ing and Sales
• Close co­oper­a­tion with part­ners with­in the coun­tries on stra­tegic and reg­u­lat­ory is­sues

• Uni­versity de­gree in nat­ur­al sci­ences (prefer­ably in the field of phar­macy, chem­istry or bio­logy)
• First pro­fes­sion­al ex­per­i­ence in the phar­ma­ceut­ic­al or health­care in­dustry in the field of in­ter­na­tion­al reg­u­lat­ory af­fairs
• Very good writ­ten and spoken Eng­lish, Rus­si­an and Ger­man, oth­er lan­guages advantageous
• Very good PC user skills (MS Of­fice)
• In­ter­cul­tur­al com­pet­ence

• A globally active, owner-managed family company with a commitment to social responsi­bility
• Flexible working time models and home office options to support work-life balance
• Responsible fields of activity with a qualified induction as well as a perfor­mance-related remunera­tion with attractive social benefits and company pension scheme
• Exciting prospects in a globally growing company with a wide range of professio­nal and personal develop­ment opportu­nities

In addition to exciting tasks and an excellent work environment, we offer you the chance to make a difference with us.

Does this job sound interesting to you? We will gladly receive your application!

Ms. Almut Waidhas (Phone: +49 9181 231-259) is looking forward to receiving your complete application documents stating the earliest possible starting date and salary expectations.

Please use our
online application form on www.bionorica.de/karriere.