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Global Director of Regulatory Affairs
  • Job type: Permanent
  • Location: Zürich
  • Salary: Competitive
  • Description Global Director of Regulatory Affairs We are recruiting for a Global Director of Regulatory Affairs to join a global biopharmaceutical company. The role is based at their global headquarters in Zurich
Regulatory Affairs Manager
  • Job type: Permanent
  • Location: Den Haag, South Holland
  • Salary: Competitive
  • Description Regulatory Affairs Manager A global biopharmaceutical area is hiring a Regulatory Affairs Manager to contribute to the development of their European operations from South Holland, the Netherlands
Senior Manager CMC Regulatory Affairs
  • Job type: Permanent
  • Location: Munich, Bayern
  • Salary: €80000 - €100000 per annum
  • Description Senior Manager CMC Regulatory Affairs A ground-breaking and innovative biotechnology company is recruiting a Senior Manager CMC Regulatory Affairs at their Global Head-Quarters in Munich, Germany
Regulatory Affairs Specailist
  • Job type: Permanent
  • Location: Leipzig, Sachsen
  • Salary: Competitive
  • Description Job Description Job type: Permanent Location: Leipzig A world leading medical device company is currently looking to hire a Regulatory Affairs Specialist to support the Quality Assurance &

Regulatory affairs officers are the link between your company, its products and regulatory authorities. In this role, your knowledge of scientific, business and legal issues is utilized to ensure that products meet the required legislation. Your primary goal is to ensure that all products are distributed and manufactured in compliance with government policies and regulations, in order to ensure their safety and efficacy.

Job Specification, Outlook and Salary 
Regulatory Affairs professionals oversee a product throughout its development as it obtains government regulatory approval, and handle various procedures to ensure proper regulatory compliance within an organisation. 
Working hours are typically office hours, but may require some longer hours to meet tight deadlines. There are generally part-time opportunities, and with experience, it's also possible to work on a self-employed basis, or to freelance through agencies.
This is a desk-based role, involving the close study of legal and scientific documents. You may often work as part of a project-team, alongside scientific and medical colleagues. Depending on the size of the company, you may work within a regulatory affairs department; smaller companies may employee only one or two specialist staff. 

How much can you earn in regulatory affairs? This depends on several factors, but the average salary for regulatory affairs specialists in the United States is $62, 000, with managerial roles attracting an average salary of around $99, 800.  In the United Kingdom, starting salaries for those with one to two years of experience range between £20,000 - £30,000. For more experienced regulatory affairs professionals, salaries range from £30,000 to £50,000, and senior or managerial positions can attract salaries of between £50,000 to £70,000. For those with extensive experience, salaries can rise to in excess of £100, 000 for associate director or director level positions. Factors affecting salary include the type of employer, your qualifications and experience, and job location. 

Typical employers are companies that develop and manufacture: 

  • Pharmaceuticals 
  • Medical devices 
  • Food/nutritional products
  • Pesticides 
  • Cosmetics
  • Biotechnology
  • Veterinary treatment 

Typical Responsibilities:

  • Preparing documentation
  • Inspecting scientific and legal documents
  • Maintaining familiarity with company products
  • Maintaining compliance with regulations of The Medicines and Healthcare products Regulatory Agency (MHRA)
  • Compiling, analyzing, organizing, managing and putting together information in different formats
  • Organizing, performing, and supervising product trials and regulatory inspections
  • Providing information about company policies, systems, and practices
  • Providing information about regulations to manufacturers and scientists
  • Keeping up with new changes in regulatory legislation and guidelines
  • Securing marketing permission
  • Evaluating complicated reports, including trial data
  • Utilizing specialized computer applications
  • Outlining requirements for labelling, storage and packaging
  • Negotiating and liaising with regulatory authorities
  • Drafting concise, user-friendly, and clear product information labels and leaflets 
  • Making sure that quality standards are achieved and submissions meet deadlines

Key Skills & Qualifications
A solid honours degree is generally the minimum requirement to work as a regulatory affairs officer. Relevant degree subjects include physical, mathematical, applied, life and medical sciences. For those looking to progress to senior-level roles, obtaining a master’s degree can provide a competitive edge. Experience in regulatory affairs, practical research, postdoctoral research, and laboratory work is also an advantage. 

Required Job Skills 

  • Solid understanding of both legal and scientific matters
  • Competency in evaluating scientific data
  • Excellent analytical skills and the ability to problem-solve
  • The ability to work under pressure and to strict deadlines
  • Excellent communication skills - written and verbal
  • An awareness of the legislation governing product approval
  • Meticulous attention to detail
  • IT skills, including familiarity with and commercial software
  • Team-working skills and the ability to lead, manage and motivate others
  • A diligent and professional approach to work
  • Tact, diplomacy and negotiation skills