Compliance/Regulatory Affairs Manager

Introduction

Compliance/Regulatory Affairs Managers are a vital link in the chain between manufacturers and service providers and the public they serve. Their importance to organisations has grown enormously in recent years in line with increasingly complex local and international regulation, which is often changing frequently. Compliance managers work closely with state agencies and local regulatory agencies on specific issues affecting their business. For example a compliance officer in the pharma or medical devices sectors works with the European Medicines Agency or the US Food and Drug Administration. They are the eyes and ears of a company when it comes to corporate responsibility in a rapidly changing compliance environment.

Alternative job titles for this role

• Compliance officer
• Regulatory affairs officer/Manager
• Compliance specialist

What the job involves

• Studying scientific and legal documents
• Gathering, evaluating, organising, managing and collating information in a variety of formats
• Maintain familiarity with company product ranges
• Plan, undertake and oversee product trials and regulatory inspections
• Keep up to date with changes in regulatory legislation and guidelines
• Analyse complicated information, including trial data
• Offer advice about company policies, practices and systems
• Obtain marketing permission
• Outline requirements for labelling, storage and packaging
• Use a variety of specialist computer applications
• Liaise and negotiate with regulatory authorities
• Provide advice about regulations to manufacturers/scientists
• Write comprehensible, user-friendly, clear, product information leaflets and labels
• Ensure that quality standards are met and submissions meet strict deadlines
• Prepare documentation

How your career can develop

Career path options for graduates are wide and varied and experienced compliance officers and managers are in big demand. Usually, experience in a specific industry is a requirement for advancement.

Why it matters

Compliance officers have a great deal of responsibility. In the wake of the financial crisis, many firms have now hired compliance officers in order to prevent similar mistakes being made in the future.

Skills

• IT skills
• Negotiation skills
• Analytical skills
• Time management skills
• Problem-solving skills
• Presentation skills
• Interpersonal skills
• Communication skills
• An understanding and appreciation of relevant legal, scientific and manufacturing areas

Typical employers

• Chemicals manufacturers
• Pharmaceuticals manufacturers
• Herbal treatments manufacturers
• Pesticides manufacturers
• Medical devices manufacturers
• Veterinary treatment manufacturers
• Research organisations
• Banks and central banks/financial regulators
• Insurance companies
• Energy providers and distributors

Typical salary

• Graduate/Starting Approx. €40,000
• Senior/Potential up to €90,000

Typical qualifications

Generally, a degree in life science-related discipline and 2 to 5 years’ relevant experience in regulatory project management and/or Senior Regulatory Affairs level responsibilities is required.