pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Regulis, part of Pharmalex UK 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.

 

Senior Regulatory Affairs Executive, Medicines
To provide high-quality regulatory consultancy to clients.  To act with a significant degree of independence to manage regulatory tasks and projects, with guidance from the Regulatory Affairs Manager.  To proactively maintain regulatory knowledge.  To deliver projects on schedule and within the agreed budget.  To strengthen and enhance the reputation that Regulis Consulting has for providing high quality regulatory consultancy services. To build positive working relationships with clients and regulatory agencies.
.

Your Job

  • Establish and maintain excellent working relationships with client companies and their personnel.
  • Advise clients on any compliance gaps.
  • Communicate legislative developments to clients in a timely manner.
  • Prepare, submit and gain approval of wide range and pre- and post-approval regulatory applications to regulatory agencies.
  • Interpret and respond to regulatory questions to resolve issues.
  • Assess scientific data and prepare scientific documents to support regulatory applications.
  • Build strong working relationships with regulatory agency personnel.
  • Execute projects and monitor progress to meet defined objectives and timescales.
  • Draft and review key regulatory documents including product labelling and module 3, overviews/summaries etc.
  • Develop and maintain a thorough knowledge of UK, EU national and pan-EU regulatory requirements.
  • Identify and assess emerging regulatory intelligence and to share this information with other colleagues and clients.
  • Build and maintain strong working relationships with client company personnel.
  • Travel to client meetings in the UK and abroad as required by the business.
  • Be flexible to respond to client demands (sometimes outside normal office hours).
  • To be aware of potential new business opportunities from existing clients and communicate this to the Regulatory Affairs Manager.
  • To communicate with the Project Manager when projects are complete or when agreed timelines have significantly delayed.
  • To provide regulatory guidance to more junior members of the team and assist with peer reviews, when necessary.

Your Profile

  • University degree in pharmacy or other natural sciences
  • Proven experience in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects
  • Ability to implement tactical goals of customer or internal projects within daily work
  • Structured, analytical, systematic and independent manner
  • Capability of supervision, 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
  • English language fluency, written and spoken

We offer

  • 25 Days holiday plus BH
  •  The role can be based at any of our UK locations.
  • An opportunity to work within an organisation with a positive work/life balance environment 
  • Continuous development opportunities through knowledge and experience as well as training



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 receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position,  including your salary expectations on-line.

To apply,  please use the  "apply now"  button below

Agencies only by prior agreement for the specific job opportunity.