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Regulatory Affairs Assistant / Specialist (m/f)
Our multinational Client AbbVie is a company that takes on the toughest health challenges, they do more than treat diseases, they aim to make a remarkable impact on people’s lives.
AbbVie is a highly focused research-driven biopharmaceutical company, premium manufacturer and market leader who constructs highly sofisticated technologies and provides complete service and maintanance for their costumers.
On behalf of our Client, we are advertising the following position:
Sarajevo, Bosnia and Herzegovina
Position description:
- Ensure that all regulatory submissions are prepared and reviewed in a timely manner for all AbbVie products in Bosnia and Herzegovina
- Gather a thorough knowledge of the registration files and all related company product documentation
- Review registration packages prior to submission to ensure compliance with local and corporate requirements.
- Manage information requests from local Regulatory Authority in a timely manner, ensuring local authority’s expectations are accurately translated for AbbVie Area Regulatory
- Ensure that all local product information (PI) and related documents submitted to Bosnian National Regulatory Authority are uploaded to appropriate Labeling System in timely manner
- Notify immediately of awareness of any regulatory requests, including safety labelling changes, urgent safety restriction requests, as well as external inspections
- Ensure compliance with AbbVie’s corporate policies, procedures and guidelines as well as with local regulations to meet statutory, quality and business requirements within the overall strategy and objectives of the AFFILIATE
- To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie
- University degree and preferably 1-2 years of experience in regulatory affairs
- Previous experience of working within the pharmaceutical industry and, in particular, Regulatory Affairs
- Significant knowledge National Regulatory processes
- Creative self-starter ready to develop in his role
- Good problem-solving skills and the ability to work to tight deadlines
- Good communications skills
- Team player with the ability to work cross-functionally
- Thorough attention to detail and high standards of accuracy
- Proficiency in written/ verbal English language
- IT conversant/Valid driving license preferable
- AbbVie’s approach to benefits, compensation and well-being, called Total Rewards is designed to be competitive and align with AbbVie’s Talent Philosophy of recognizing and rewarding individual performance
- AbbVie’s care about what’s important to the employees
- AbbVie Vitality is approach to employee well-being and encompasses a wide range of events, programs and resources. It’s about sustaining healthy behaviours, so each person performs their best inside and outside the workplace
Svu proceduru oko ishođenja dozvole za boravak i rad obezbjeđuje Poslodavac. Obezbijeđen je i plaćen smještaj u kvalitetno opremljenim apartmanima. Poslodavac snosi troškove putovanja zaposlenika.
Please send your application and CV in English, with full confidentiality, to the following e-mail:
e-mail: [email protected] or
APPLICATION LINK
Closing date for applications is 20.04.2022.
Any additional information can be obtained on tell +387 33 29 52 54
Note: Please be informed that only short-listed candidates will be contacted and invited for an interview. Thank you for understanding.
