International Regulatory Affairs, PV & Quality Assurance Manager for CEE Region (f/m)

December 15, 2021 1:00 pm Published by
Ena Mehulić
Objavljeno
15.12.2021
Lokacija:
Bratislava
Vrsta posla:

Opis posla

Adecco is the world's leading provider of HR services. We connect over 700,000 people with employers every day. We operate in more than 60 countries, with over 32,000 employees in 5,100 branches.

For our client, Swedish Orphan Biovitrum (Sobi), an international biopharmaceutical company focused on rare diseases which provide innovative treatments that transform lives, we are looking for a new team member on the following position:

International Regulatory Affairs, PV & Quality Assurance Manager for CEE Region (f/m)
Location: Bratslava or Prague office

Salary: Starting at 3800 EUR per month gross or higher according to qualifications

Key responsibilities:

Regulatory affairs (50%):
• Project Management of regional RA aspects in close cooperation with Global Regulatory Affairs (GRA) as well as local regulatory consultants in each country
• Supporting applications and handling of marketing authorizations in the CEE region (EU countries and secondarily, selected non-EU markets) - new approval procedures as well as change and renewal procedures for products already on the market
• Coordinating revision and adaptation of labeling documents including tracking of updates and their implementation between GRA and local consultants
• Revision of approval documents including tracking of updates and respective handling of databases and document management systems
• Collaboration with GRA on approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in non-EU markets, as needed, as well as of lifecycle management procedures (e.g. variations, renewals, MAH transfer) worldwide
• Communication and interaction within the HQ office, project team, with customers, local partners and authorities in a regional and/or an international context
• Organization of the planning and coordination of all approval-relevant procedures, including monitoring of deadlines and compliance with deadlines

Pharmacovigilance (25%):
• Representation of the regional PV aspects in an international environment and close cooperation with Global Pharmacovigilance (GPV) and Global vendor for PV Services
• Ensuring a local and global PV requirements are implemented in the region
• Communication and interaction within the HQ office, project team, with customers, local partners and authorities in a regional and/or an international context

Quality Assurance (25%):
• Ensuring a functioning quality management system for the region in compliance with Global and regional SOPs and their ongoing updates
• Ensure audit and inspection readiness
• Ensuring timely processing of action plans / CAPAs and ensuring their implementation and documentation
• Ensuring the implementation of training courses
• Ensuring that all incoming complaints are properly recorded, assessed, forwarded and documented
• Ensuring that the complaint procedures set out in SOPs are adhered to

Your Profile:
• You have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor’s degree in science, engineering or mathematical domain
• You speak fluent English (at least on B2 level)
• You have at least 2 - 3 years of professional experience in regulatory affairs and additionally pharmacovigilance & quality assurance in CEE region or adjacent relevant geography
• You bring experience in handling of marketing authorizations and their lifecycle management with a focus on the EU
• Experience in regulatory applications and handling of non-EU marketing authorization procedures is appreciated
• You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region
• You have an affinity for databases and project management software tools and are used to closely monitor and adhere to timelines
• You are a team player, communicative, conscientious, accurate and responsible
• Confident with MS Excel and MS Word as well as databases and document management system

They offer:

• A diverse and challenging job
• Open and appreciative corporate culture
• Flexible working hours based on trust
• Possibility to work from home
• Continuous development opportunities through knowledge and experience as well as training

If you would like to be part of an innovative team and work in a dynamic and motivating environment, please send us your CV via the application link

Apply here!

Note: only shortlisted candidates will be contacted.

Adecco Croatia d.o.o. obtained a license to perform activities related to employment by the Ministry of Economy, Labor and Entrepreneurship class: UP / I-102-02 / 20-03 / 13 from 13.02.2020.

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