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Specialist Regulatory Affairs Operations (m/f) Sofia Bulgaria,  

PHARMALEX (company)

Posted on : 13 June 2017

Project Description

Be a part of our growing company!
  • Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life? 
  • Then make our company your career choice! our company is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting.
  •  We are specialized in effectively designing all aspects of drug and medicinal product registrations  ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.
  • We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. 
  • So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. 

Specialist Regulatory Operations (m/f)
 Your responsibilities
  • Preparation of electronic applications in particular in the eCTD format for approval according to the requirements of the relevant authorities (Europe, USA, etc.) including preparation of proposals, project planning and tracking
  • Creation, compilation and validation of electronic submissions (e.g. eCTD, NeeS) for all types of regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals) in ICH and non-ICH-areas using available software
  • Realisation of Regulatory Operations projects, including communication with clients and authorities
  • Support consulting for clients concerning implementation and optimisation of electronic submissions and document management systems
  • Ensure the consistency, integrity and correctness of the data in the regulatory IT systems and quality assurance (e.g. preparation of SOPs and WIs and corresponding  training)
  • Administration of docuBridge and other software specific to Regulatory Operations (e.g. updates, validation, maintenance)
  • Collaboration in the optimization of departmental and inter-departmental processes and acting as interface to IT department
  • Communication in the project team, with customers, local partners and representatives in the international context

 Your profile
  • Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology) or medical informatics
  • At least 1 year of professional experience
  • Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on Regulatory Operations aspects
  • Professional experience in the area of eCTD
  • Capability of supervision, prioritization and processing of parallel projects and tasks
  • Analytical, systematic, solution-oriented thinking
  • High service orientation and structured, reliable and accurate approach
  • Team-oriented, communicative and conscientious
  • Professional written and spoken communication skills as well as confident English skill
  • Secure MS Office knowledge, Adobe Acrobat and database systems

We offer you
Exciting and varied challenges in a friendly team, contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training.



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