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Ovaj oglas je istekao 19.12.2014. i više nije aktivan.
Sadržaj oglasa prikazan je isključivo u informativne svrhe.
Trenutno aktivne oglase pogledajte na www.posao.hr.
Head of Regulatory Affairs (m/f)
Oglas je istekao
Poslodavac:
Kategorija:
Mjesto rada:
Zagreb
Rok prijave:
19.12.2014.
O poslu
Opis radnog mjesta:
NatonHR agency is looking for a candidate for the position:
Head of Regulatory Affairs for a pharmaceutical company
Zagreb, Croatia
Role Purpose
Provide advice and prepare regulatory submissions for Croatian market (national applications and local requirements and national phase documents for DCP and MRP submissions) and for other Adria markets as required for business needs.
Ensure efficient and timely approval of submissions and life cycle management activities to support on time registrations and maintenance of product registrations and product launches and on-going supply in the local markets.
Support distribution activities in Croatia as Responsible Person for warehouse.
Key Responsibilities and Accountabilities
Preparation of local (national) documentation for new MA applications (national/DCP/MRP) and post-approval documentation (pricing and reimbursement, variations, renewals etc.) in accordance with company business needs.
Submission of applications as above in compliance with Competent Authority requirements and communication with Authority to ensure requests for information and all issues are resolved promptly.
Monitor and follow up of registration procedures appropriately.
Provide high quality translations as necessary for applications, including labelling, and to company colleagues to ensure timely and accurate documentation is shared.
Review and approve local product artwork.
Maintain up to date regulatory intelligence of local markets, communicating to all functions any relevant information and updates to ensure accurate submissions and that compliance with all local requirements is achieved and maintained.
Liaise with and provide data to any company function or consultant as required ensuring all regulatory and pharmacovigilance or related scientific services requirements are fulfilled.
Maintain relevant databases in accordance with company procedures.
Review Technical Agreements
Act as Responsible Person for local wholesale dealer’s licence to ensure compliance with GDP requirements.
Train internal staff as needed, within the remit of the job profile.
Key Interactions
Internal:
- EU-located regulatory affairs personnel
- XXXXX-located regulatory affairs personnel
- Quality and manufacturing - including packaging, EU - QP and these functions within the local markets
- Warehouse staff and supply chain staff
- Commercial and managerial functions in the Croatian - Pharma Company and elsewhere in Europe (most particularly for the Eastern Cluster)
- Portfolio staff
External:
- Regulatory Authorities in Croatia and the Adriatic region
- Pharmacovigilance provider (QPPV)
- Consultants and contractors for regulatory or scientific or technical services including batch testing and release sites
Head of Regulatory Affairs for a pharmaceutical company
Zagreb, Croatia
Role Purpose
Provide advice and prepare regulatory submissions for Croatian market (national applications and local requirements and national phase documents for DCP and MRP submissions) and for other Adria markets as required for business needs.
Ensure efficient and timely approval of submissions and life cycle management activities to support on time registrations and maintenance of product registrations and product launches and on-going supply in the local markets.
Support distribution activities in Croatia as Responsible Person for warehouse.
Key Responsibilities and Accountabilities
Preparation of local (national) documentation for new MA applications (national/DCP/MRP) and post-approval documentation (pricing and reimbursement, variations, renewals etc.) in accordance with company business needs.
Submission of applications as above in compliance with Competent Authority requirements and communication with Authority to ensure requests for information and all issues are resolved promptly.
Monitor and follow up of registration procedures appropriately.
Provide high quality translations as necessary for applications, including labelling, and to company colleagues to ensure timely and accurate documentation is shared.
Review and approve local product artwork.
Maintain up to date regulatory intelligence of local markets, communicating to all functions any relevant information and updates to ensure accurate submissions and that compliance with all local requirements is achieved and maintained.
Liaise with and provide data to any company function or consultant as required ensuring all regulatory and pharmacovigilance or related scientific services requirements are fulfilled.
Maintain relevant databases in accordance with company procedures.
Review Technical Agreements
Act as Responsible Person for local wholesale dealer’s licence to ensure compliance with GDP requirements.
Train internal staff as needed, within the remit of the job profile.
Key Interactions
Internal:
- EU-located regulatory affairs personnel
- XXXXX-located regulatory affairs personnel
- Quality and manufacturing - including packaging, EU - QP and these functions within the local markets
- Warehouse staff and supply chain staff
- Commercial and managerial functions in the Croatian - Pharma Company and elsewhere in Europe (most particularly for the Eastern Cluster)
- Portfolio staff
External:
- Regulatory Authorities in Croatia and the Adriatic region
- Pharmacovigilance provider (QPPV)
- Consultants and contractors for regulatory or scientific or technical services including batch testing and release sites
Vrsta posla:
stalni radni odnos
Županija:
O zaposleniku
Znanja i kvalifikacije:
Education Requirements
A Degree in Pharmacy or Pharmaceutical Sciences or related scientific subject
Certificate for English language competence or equivalent
Technical/professional expertise and Experience
Minimum 3 years’ experience in Regulatory Affairs in Croatia.
Preferably with experience in the entire Adriatic region (especially Serbia, Montenegro, Bosnia, Macedonia), also with experience of EU regulatory procedures, preferably in a pharmaceutical company with generic products.
Current ‘hands on’ experience with regulatory submissions including communication with the Regulatory Authorities.
Responsible Person capability for wholesale dealer’s licence.
Understanding of Pharmacovigilance requirements and procedures.
Understanding of EU and national rules on advertising and promotion of medicinal products.
Understanding and experience of regulatory requirements for food supplements in Europe is an advantage.
Specific skills related to the function
- excellent written and fluent oral communication in English and Croatian, because it will be used on a daily basis
- Other European languages are an advantage
- Attention to detail, accuracy in documentation
The candidate should be a responsible, hard-working, communicative and proactive person with energy and wish to advance. Some business trips are a part of this position from time to time.
The perfect candidate is expected to have the will to learn and put efforts into his/her work.
Salary/ benefits: the salary and the benefits shall be discussed at a personal interview with the client. The chosen candidates will be contacted personally by phone.
Please, send your resume in English with clearly-defined tasks at your current and ex-work positions and also be kind to answer the following questions under "Brza prijava".
Apply via link "Brza prijava". All other applications will not be accepted.
Application letters are not necessary.
Naton ljudski potencijali d.o.o. za zapošljavanje ima dozvolu Ministarstva rada i mirovinskog sustava za obavljanje djelatnosti u svezi sa zapošljavanjem klasa UP/I-102-02/14-03/09, urbroj 524-04-02-01/2-14-6
A Degree in Pharmacy or Pharmaceutical Sciences or related scientific subject
Certificate for English language competence or equivalent
Technical/professional expertise and Experience
Minimum 3 years’ experience in Regulatory Affairs in Croatia.
Preferably with experience in the entire Adriatic region (especially Serbia, Montenegro, Bosnia, Macedonia), also with experience of EU regulatory procedures, preferably in a pharmaceutical company with generic products.
Current ‘hands on’ experience with regulatory submissions including communication with the Regulatory Authorities.
Responsible Person capability for wholesale dealer’s licence.
Understanding of Pharmacovigilance requirements and procedures.
Understanding of EU and national rules on advertising and promotion of medicinal products.
Understanding and experience of regulatory requirements for food supplements in Europe is an advantage.
Specific skills related to the function
- excellent written and fluent oral communication in English and Croatian, because it will be used on a daily basis
- Other European languages are an advantage
- Attention to detail, accuracy in documentation
The candidate should be a responsible, hard-working, communicative and proactive person with energy and wish to advance. Some business trips are a part of this position from time to time.
The perfect candidate is expected to have the will to learn and put efforts into his/her work.
Salary/ benefits: the salary and the benefits shall be discussed at a personal interview with the client. The chosen candidates will be contacted personally by phone.
Please, send your resume in English with clearly-defined tasks at your current and ex-work positions and also be kind to answer the following questions under "Brza prijava".
Apply via link "Brza prijava". All other applications will not be accepted.
Application letters are not necessary.
Naton ljudski potencijali d.o.o. za zapošljavanje ima dozvolu Ministarstva rada i mirovinskog sustava za obavljanje djelatnosti u svezi sa zapošljavanjem klasa UP/I-102-02/14-03/09, urbroj 524-04-02-01/2-14-6
Minimalna stručna sprema:
Fakultet
Strani jezik:
engleski
