Profession regulatory affairs manager

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.

Personality Type

• Enterprising / Conventional

Knowledge

• 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.

• Company policies

  The set of rules that govern the activity of a company.

• Strategic planning

  The elements defining the foundation and core of an organisation such as its mission, vision, values, and objectives.

Skills

• 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.

• 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.

• 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.

• 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.

• Prepare licence agreements

  Make the legal contract ready, granting permission to use equipment, services, components, applications and intellectual property.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Monitor company policy

  Monitor the company's policy and propose improvements to the company.

• Develop licensing agreements

  Compose the conditions and terms related to assigning limited use rights for properties or services.

• Ensure compliance with company regulations

  Guarantee that employees' activities follow company regulations, as implemented through client and corporate guidelines, directives, policies and programmes.

• 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.

• Organise business documents

  Put together documents coming from the photocopier, the mail, or the daily operations of businesses.

• Interpret technical requirements

  Analyse, understand and apply the information provided regarding technical conditions.

• 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.

Optional knowledge and skills

Source: Sisyphus ODB