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Regulatory Affairs Specialist/Manager
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Industry

Life Science

Category

Research & Development

Experience

Entry level

Location: Gothenburg +4 more

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Job Description

We are growing, grow with us!

Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice! PharmaLex 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 both independently an in collaboration 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. Our Nordic Regulatory Affairs team in Swedenis growing, and we are looking for new team members based in Sweden

Your Job

As a part of our Regulatory Affairs team, your duties will primarily include planning, preparation and submission of regulatory documentation. The main responsibilities of the Regulatory Affairs Manager/Specialist will include:

  • Participation in regulatory processes to gain and maintain marketing authorizations (applications, renewals and variations)
  • Evaluation, preparation, revision and compilation of regulatory documentation
  • Planning, filling and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and potentially worldwide as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.)
  • Advise clients on regulatory strategy and fit this to the client’s overall business objectives
  • General guidance (consultancy) regarding Regulatory Submissions & Labelling
  • Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
  • Communication with the client and the Health Authorities
  • Interpret and respond to regulatory questions to resolve issues
  • On occasion working in a client’s office may be necessary for certain short-term projects
  • Contribution to optimizing departmental internal processes
  • Active contribution and distribution of department relevant expertise
Skills & Requirements

Your Profile

  • Proven experience within Regulatory Affairs e.g. evaluation, preparation and compilation of regulatory documentation and/or experience in regulatory processes (registration procedures, renewals, variation procedures) is an advantage but not a requirement. We are looking for more regulatory colleagues and we have in-house experts to provide great learning and development opportunites.
  • University degree in pharmacy or other life sciences
  • Ability to implement tactical goals of customer or internal projects within daily work
  • Structured, analytical, systematic and independent manner
  • Capability of prioritization and processing of parallel projects and tasks
  • High service orientation
  • Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
  • Excellent team player
  • Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
  • Language fluency in English and Swedish, written and spoken

We offer

  • External business interaction with clients and internal collaboration within the PharmaLex organization
  • Broad range of initiatives for personal development and professional training
  • Exciting and varied challenges in a friendly and openminded work environment in a global organization
About the company

PharmaLex is one of the leading service companies for the pharmaceutical industry globally and is specialized in all aspects of drugs and medical devices approval, of the development to market and any action of effective product maintenance. PharmaLex values includes international mindset, growth & learning, collaboration, quality focus, dynamic working approach and integrity & respect.

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