pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. 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 market development and any action of effective product maintenance.

 

Regulatory Affairs Assistant


Your Job

As a part of our Regulatory Affairs team, your duties will include planning, preparation and submission of regulatory documentation, primarily product information. The main responsibilities of the Regulatory Affairs Assistant will include:
 
  • Participation in the preparation, revision, translation and proofreading of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
  • General guidance (consultancy) about regulatory requirements regarding product information (SmPC, PIL, Labelling) and other relevant regulatory activities 
  • Coordinating activities in relation with product information and other regulatory activities as relevant, including liaising with clients, subcontractors and authorities.
  • Participate in compliance of marketing material
  • Interpret and respond to regulatory questions to resolve issues
  • Contribution to optimizing departmental internal processes
  • Active contribution and distribution of department relevant expertise
  • Ad hoc tasks within registration of pharmaceutical products and related areas


Your Profile

  • Proven experience within Regulatory Affairs e.g. preparation of product information,  compliance check of marketing material and/or other regulatory activities e.g. renewals and variations is a plus. However since we are looking for more regulatory colleagues this is not a must but can be developed.
  • Relevant educational background could be e.g. Nurse, Pharmaconomist or Correspondent
  • Structured, analytical, systematic and independent manner
  • Capability of prioritization and processing of parallel activities 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 Danish, 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



If you are interested in joining our Pharmalex team, taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents as soon as possible. The recruitment is done on a continual basis.

Agencies only by prior agreement for the specific job opportunity.