Regulatory affairs manager

Description

Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the different phases of regulatory processes and act as an interface between business and government legislation or regulatory boards.

Other titles

The following job titles also refer to regulatory affairs manager:

regulatory compliance manager
regulatory affairs officer
compliance manager
chief compliance officer
regulatory affairs specialist
regulatory affairs portfolio leader
bank compliance officer
regulatory manager
regulatory compliance officer

Minimum qualifications

Bachelor’s degree is generally required to work as regulatory affairs manager. However, this requirement may differ in some countries.

ISCO skill level

ISCO skill level is defined as a function of the complexity and range of tasks and duties to be performed in an occupation. It is measured on a scale from 1 to 4, with 1 the lowest level and 4 the highest, by considering:

  • the nature of the work performed in an occupation in relation to the characteristic tasks and duties
  • the level of formal education required for competent performance of the tasks and duties involved and
  • the amount of informal on-the-job training and/or previous experience in a related occupation required for competent performance of these tasks and duties.

Regulatory affairs manager is a Skill level 4 occupation.

Regulatory affairs manager career path

Similar occupations

These occupations, although different, require a lot of knowledge and skills similar to regulatory affairs manager.

policy manager
strategic planning manager
environmental protection manager
business intelligence manager
tax policy analyst

Long term prospects

These occupations require some skills and knowledge of regulatory affairs manager. They also require other skills and knowledge, but at a higher ISCO skill level, meaning these occupations are accessible from a position of regulatory affairs manager with a significant experience and/or extensive training.

Essential knowledge and skills

Essential knowledge

This knowledge should be acquired through learning to fulfill the role of regulatory affairs manager.

Organisational policies: The policies to achieve set of goals and targets regarding the development and maintenance of an organisation.
Business analysis: The research field which addresses the identification of business needs and problems and the determination of the solutions that would mitigate or prevent the smooth functioning of a business. Business analysis comprises IT solutions, market challenges, policy development and strategic matters.
Strategic planning: The elements defining the foundation and core of an organisation such as its mission, vision, values, and objectives.
Company policies: The set of rules that govern the activity of a company.

Essential skills and competences

These skills are necessary for the role of regulatory affairs manager.

Integrate strategic foundation in daily performance: Reflect on the strategic foundation of companies, meaning their mission, vision, and values in order to integrate this foundation in the performance of the job position.
Prepare licence agreements: Make the legal contract ready, granting permission to use equipment, services, components, applications and intellectual property.
Ensure compliance with legal requirements: Guarantee compliance with established and applicable standards and legal requirements such as specifications, policies, standards or law for the goal that organisations aspire to achieve in their efforts.
Enforce financial policies: Read, understand, and enforce the abidance of the financial policies of the company in regards with all the fiscal and accounting proceedings of the organisation.
Develop organisational policies: Develop and supervise the implementation of policies aimed at documenting and detailing the procedures for the operations of the organisation in the lights of its strategic planning.
Organise business documents: Put together documents coming from the photocopier, the mail, or the daily operations of businesses.
Ensure compliance with company regulations: Guarantee that employees’ activities follow company regulations, as implemented through client and corporate guidelines, directives, policies and programmes.
Meet the requirements of legal bodies: Ensure the practice methods and procedures used are in compliance with the regulations and requirements of the legal governing authority in the field.
Analyse legislation: Analyse the existing legislation from a national or local government in order to assess which improvements could be made and which items of legislation could be proposed.
Monitor compliance with licensing agreements: Ensure that licensee is well aware of all terms, legal aspects and renewal aspects of the license that has been awarded.
Monitor company policy: Monitor the company’s policy and propose improvements to the company.
Advise on efficiency improvements: Analyse information and details of processes and products in order to advise on possible efficiency improvements that could be implemented and would signify a better use of resources.
Develop licensing agreements: Compose the conditions and terms related to assigning limited use rights for properties or services.
Identify legal requirements: Conduct research for applicable legal and normative procedures and standards, analyse and derive legal requirements that apply to the organisation, its policies and products.
Develop company strategies: Envision, plan, and develop strategies for companies and organisations aimed at achieving different purposes such as establishing new markets, refurbishing the equipment and machinery of a company, implementing pricing strategies, etc.
Ensure compliance with policies: Ensure compliance with legislation and company procedures in respect of health and safety in the workplace and public areas. Ensure awareness and compliance with all company policies in relation to health and safety and equal opportunities in the workplace.
Interpret technical requirements: Analyse, understand and apply the information provided regarding technical conditions.
Ensure products meet regulatory requirements: Study, implement, and monitor the integrity and compliance of products with the required regulatory aspects by law. Advise on applying and abiding by regulations on the product and manufacturing regulations.
Implement strategic planning: Take action on the goals and procedures defined at a strategic level in order to mobilise resources and pursue the established strategies.

Optional knowledge and skills

Optional knowledge

This knowledge is sometimes, but not always, required for the role of regulatory affairs manager. However, mastering this knowledge allows you to have more opportunities for career development.

Financial products: The different types of instruments that apply to the management of cash flow that are available on the market, such as shares, bonds, options or funds.
International trade: The economic practise and study field that address the exchange of goods and services across geographic borders. The general theories and schools of thought around the implications of international trade in terms of exports, imports, competitivity, GDP, and role of multinational companies.
Patents: The exclusive rights granted by a sovereign state to an inventor’s invention for a limited period of time in exchange for the public disclosure of the invention.
Intellectual property law: The regulations that govern the set of rights protecting products of the intellect from unlawful infringement.
Hazard analysis and critical control points: The field of hazard analysis in order to ensure maximal safety conditions.
Banking activities: The broad and continuously growing banking activities and financial products managed by banks ranging from personal banking, corporate banking, investment banking, private banking, up to insurance, foreign exchange trading, commodity trading, trading in equities, futures and options trading.
Law enforcement: The different organisations involved in law enforcement, as well as the laws and regulations in law enforcement procedures.
Corporate social responsibility: The handling or managing of business processes in a responsible and ethical manner considering the economic responsibility towards shareholders as equally important as the responsibility towards environmental and social stakeholders.
Nuclear legislation: Be familiar with European, national and international legislation regarding the practice of nuclear activities.
Quality standards: The national and international requirements, specifications and guidelines to ensure that products, services and processes are of good quality and fit for purpose.
Tax legislation: Tax legislation applicable to a specific area of specialisation, such as import tax, government tax, etc.
Corporate law: The legal rules that govern how corporate stakeholders (such as shareholders, employees, directors, consumers, etc) interact with one another, and the responsibilities corporations have to their stakeholders.
Copyright legislation: Legislation describing the protection of the rights of original authors over their work, and how others can use it.
Financial jurisdiction: Financial rules and procedures applicable to a certain location, whose regulatory bodies decide on its jurisdiction

Optional skills and competences

These skills and competences are sometimes, but not always, required for the role of regulatory affairs manager. However, mastering these skills and competences allows you to have more opportunities for career development.

Analyse scientific data: Collect and analyse scientific data resulting from research. Interpret these data according to certain standards and viewpoints in order to comment on it.
Contact scientists: Listen, reply, and establish a fluid communication relationship with scientists in order to extrapolate their findings and information into a varied array of applications including business and industry.
Support managers: Provide support and solutions to managers and directors in regards with their business needs and requests for the running of a business or the daily operations of a business unit.
Identify hazards in the workplace: Perform safety audits and inspections on workplaces and workplace equipment. Ensure that they meet safety regulations and identify hazards and risks.
Communicate with banking professionals: Communicate with professionals in the field of banking in order to obtain information on a specific financial case or project for personal or business purposes, or on behalf of a client.
Keep updated on innovations in various business fields: Be informed and acquainted with innovations and trends in different industrial and business fields for application in business development.
Advise on legal decisions: Advise judges, or other officials in legal decision-making positions, on which decision would be right, compliant with the law and with moral considerations, or most advantageous for the adviser’s client, in a specific case.
Provide legal advice: Provide advice to clients in order to ensure that their actions are compliant with the law, as well as most beneficial for their situation and specific case, such as providing information, documentation, or advice on the course of action for a client should they want to take legal action or legal action is taken against them.
Analyse enforceability: Examine the client’s present situation, ideas and wishes under a legal perspective to assess their legal justification or enforceability.

ISCO group and title

2619 – Legal professionals not elsewhere classified

 

 


 

 

References
  1. Regulatory affairs manager – ESCO
Last updated on August 8, 2022