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.

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Personality Type

  • Enterprising / Conventional

Knowledge

  • Company policies

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

  • Organisational policies

    The policies to achieve set of goals and targets regarding the development and maintenance of an organisation.

  • Strategic planning

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

  • 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.

Skills

  • 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.

  • 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.

  • 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.

  • Prepare licence agreements

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

  • 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.

  • Interpret technical requirements

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

  • 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.

  • 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.

  • 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.

  • Organise business documents

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

  • 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.

  • 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.

  • 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.

  • Ensure compliance with policies

    To ensure compliance with legislation and company procedures in respect of Health and Safety in the workplace and public areas, at all times. To ensure awareness of and compliance with all Company Policies in relation to Health and Safety and Equal Opportunities in the workplace. To carry out any other duties which may reasonably be required.

  • 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.

  • 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.

  • Monitor company policy

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

  • Ensure compliance with company regulations

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

Optional knowledge and skills

intellectual property law communicate with banking professionals law enforcement banking activities corporate law hazard analysis and critical control points copyright legislation corporate social responsibility patents identify hazards in the workplace financial products tax legislation provide legal advice keep updated on innovations in various business fields quality standards support managers analyse scientific data analyse enforceability contact scientists financial jurisdiction nuclear legislation advise on legal decisions international trade

Common job titles

  • Regulatory affairs manager
  • Manager regulatory affairs
  • Manager, global regulatory affairs
  • Manager, regulatory affairs
  • Manager, regulatory affairs (device)
  • Sr mgr, regulatory affairs-pma biologics