Accessibility Links

Regulatory Affairs Jobs

Latest jobs

Director of Regulatory Affairs
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Title: Director of Regulatory Affairs Company summary: A leading, global, oncology organization is looking for an experienced professional to lead their regulatory affairs team in the Bay Area! You
Regulatory Affairs Senior Associate
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Title: Regulatory Affairs Senior Associate Company summary: A leading, multi-billion dollar global immuno-oncology company here in the Bay Area is seeking an experienced professional to come on
Regulatory Affairs Specialist
  • Job type: Permanent
  • Location: Switzerland
  • Salary: Negotiable
  • Description Regulatory Affairs Specialist A dynamic international pharmaceutical leader in drug delivery is looking to hire a Regulatory Affairs Specialist into their team
Project Manager, Regulatory Affairs
  • Job type: Permanent
  • Location: San Diego, California
  • Salary: US$70000 - US$100000 per year
  • Description Project Manager, Regulatory Affairs Looking for a Project Manager, Regulatory Affairs for one of my largest Biopharmaceutical clients in San Diego! The Project Manager is responsible for
Regulatory Affairs Specialist
  • Job type: Permanent
  • Location: Mannheim, Baden-Württemberg
  • Salary: Competitive
  • Description Job Type: Regulatory Affairs Specialist Location: Mannheim A global leader in the innovative medical device industry, paving the way in discovering treatments for patients within the Ophthalmology
Manager of Regulatory Affairs
  • Job type: Permanent
  • Location: Cambridge, Massachusetts
  • Salary: US$120000 - US$150000 per year
  • Description My client is a best-in-class viral vector contract development and manufacturing organization (CDMO) for companies developing gene-modified cell therapies and in vivo gene therapies
Regulatory Affairs Associate
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Competitive
  • Description Regulatory Affairs AssociateCompany summary: A leading biotech here in the Bay Area in the Hepatology space is currently going through an exciting period of growth across the board
Associate Director of Regulatory Affairs, CMC
  • Job type: Permanent
  • Location: New Jersey
  • Salary: US$140000 - US$160000 per year
  • Description My client is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic brand, OTC and bio-similar products to patients around the world and they 350
Associate Director of Regulatory Affairs
  • Job type: Permanent
  • Location: New York
  • Salary: US$165000 - US$200000 per year
  • Description My client is looking for an Associate Director of Regulatory Affairs. This person will be responsible for overseeing the regulatory affairs department and all activities associated with the

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