Regulatory Affairs Project Manager

OVERVIEW

Pharmexon Consulting is a dynamic Consultancy company for the pharmaceutical industry, specialized in offering full support for registration and approval of medicines in Europe. Our client base is worldwide and as we are rapidly growing, we seek to find people who would complement our teams and support us maintain and develop the current client base.

The Company is now facing an exciting time with further expansion of the business, leading to a number of opportunities arising in join our team. You will be based in our office in Prague (CR), working within an excellent environment in a friendly, professional team who will train and support you to meet the highest level of quality and client’s expectations. The successful candidate will receive full mentoring and training by ex-Health Agency level experts, continuing education in Regulatory matters and exposure to interesting Regulatory scenarios.

MAIN PURPOSE OF ROLE

Responsibilities will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs and Drug Development for pharmaceuticals for human use and/or Pharmacovigilance support. Any knowledge or experience in this area would be useful.

The RA manager will play an integral role in working with our clients and manage & support a variety of projects, interface with clients for new products and compliance-related issues. You will work closely with colleagues across the team and be a key contact for clients. Not only will the role develop your regulatory expertise and technical knowledge, it will also develop your client-facing skills.

KEY RESPONSIBILITIES

  • Coordinating the entire projects with internal and external teams, making sure that timelines and projects are being delivered on time
  • Give clear instructions and complete details about projects to internal and external teams
  • Becoming familiar with the EU regulation and additionally other regional regulations
  • Client-facing responsibilities

SKILLS REQUIRED

  • Relevant Degree in Science or related Discipline
  • Regulatory experience within pharmaceutical industry (desirable)
  • Strong Project Management Skills and excellent attention to detail
  • Proficiency with Project Management Software and document management
  • Scientific knowledge sufficient to understand regulatory issues and affiliate scientific discussions
  • Ability to work independently or as part of a team
  • Good time planning skills
  • Must be flexible and adaptable to changing project priorities and work assignments
  • Excellent written and oral communication skills required, attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage

COMMERCIAL OFFER

  • Competetive salary
  • Salary negotiable and commensurate with experience
  • Flexible working hours and/or part-time position available
  • Visa support for non-EU residents