Regulatory Affairs Managers

Legal & Corporate Governance

Level 6664 of 1200 points

Job description

Regulatory Affairs Managers

Job purpose

To plan, direct and coordinate the organisation's regulatory affairs function, setting regulatory strategy, directing agency submissions and managing audits, inspections and recalls, so that products and production comply with domestic and international regulation and dealings with agencies are accurate and timely.

Skills

Command of the regulation governing the organisation's products and production, domestic and international, including agency rules and rules still in passage; the management principles needed for planning, resource allocation and leadership of a function; biological and chemical subject matter sufficient to judge product, clinical trial and toxic substance questions; and submission publishing practice. A bachelor's degree is the norm, with a minority holding a master's and a small number a doctorate, together with several years of related experience.
Represents the organisation before domestic and international regulatory agencies on major policy matters and product decisions, and responds to them on product information. Communicates regulatory information to multiple departments and ensures it is interpreted correctly, advises project teams on the regulatory aspects of design, development and marketing, and coordinates depositions with legal staff. Directs, guides and trains subordinate staff.
Judges whether submissions, marketing literature and user manuals meet agency requirements; investigates product complaints and determines what must be reported; decides how the organisation responds during audits, inspections and recalls; and reads emerging rules for their impact on internal processes. Regulation and internal procedure supply the framework, but applying it to a new product or an unsettled rule calls for judgement, and decisions carry consequences for co-workers and company results.
Develops regulatory strategies and implementation plans for new product submissions, formulates regulatory policies and standard operating practices, and contributes to business unit strategic and operating plans. Establishes regulatory priorities and schedules the function's work against agency deadlines under time pressure.
Work is carried out at a desk and in meetings, using document and submission publishing systems. No manual handling or dexterity demands.

Responsibilities

Manages the regulatory affairs function and its staff: directs and guides subordinates, sets performance standards, allocates workloads, trains staff in regulatory policies and develops them, and is accountable for their work outcomes. Functional accountability extends across the organisation, since departments and project teams depend on the guidance and interpretation of regulation issued to them.
Establishes regulatory priorities and budgets for the function and allocates resources and workloads within them, and evaluates new software publishing systems. Spend is committed within the business unit plans to which the postholder contributes.
Establishes the systems by which document submissions are published in hardcopy and electronic form. Manages product recalls, which determines the disposition of product already released. Ordinary care of a workstation and of regulatory document systems.
Accountable for the completeness and integrity of the organisation's regulatory record. Reviews all agency submission material for timeliness, accuracy, comprehensiveness and compliance with regulatory standards, directs documentation to satisfy domestic and international requirements, maintains standard operating procedures and working practices, and monitors complaint processing so that investigations are resolved and recorded. Also monitors alignment with the organisation's sustainability commitments.

Effort required

Exacting review of substantial submission documentation against regulatory standards, where accuracy is the point of the work, combined with the judgement needed to read a rule for its effect on the organisation. Decisions are made frequently and under time pressure, with effects reaching co-workers and company results.
Personally accountable as the organisation's voice to regulators, standing behind the positions taken before agencies and the responses given on product issues. Manages audits, inspections, complaint investigations and recalls, and negotiates across departments to reach a common interpretation, in a commercially competitive setting.
Predominantly seated work at a desk. No lifting or exertion.

Working conditions

Indoors in environmentally controlled surroundings, without physical hazard, with a large volume of contact by e-mail, telephone and discussion with agencies, project teams and departments, and sustained work within teams. Psychosocial demand comes from the accountability attaching to regulatory dealings and from the competitive environment, not from adverse physical or personal exposure.
Hours follow a regular established schedule for almost all incumbents, with small irregular and seasonal minorities, most working more than a standard week. Determines own tasks, priorities and goals with freedom to decide within regulatory requirements and business unit plans, coordinating and leading others and deciding frequently on matters affecting co-workers and company results.

Skills

40% · 302 points▾

KnowledgeLevel 5 of 8
90 of 144 points
Specialised and theoretical knowledge within a field of work and an awareness of the limits of that knowledge. The job requires a comprehensive range of cognitive and practical knowledge to develop creative solutions to abstract problems.
Interpersonal and communication skillsLevel 4 of 5
77 of 96 points
Advanced communication and interpersonal skills. The job holder is required to manage complex interactions, mediate interpersonal conflicts and support group collaboration.
Problem-solving skillsLevel 4 of 5
77 of 96 points
Non-standard problems. The job involves solving complex, non-standard problems involving multiple factors to consider. Solutions often require careful analysis and the adaptation of current methods.
Planning and organisational skillsLevel 4 of 5
58 of 72 points
Advanced organisational skills required. The job requires planning and managing complex, often overlapping tasks or schedules. The job requires a degree of autonomy and joint planning, and managing interdependencies across teams or departments.
Physical skillsLevel 0 of 5
0 of 72 points
Not applicable. The job does not require any particular physical skills (although there is likely to be some physical activity).

Responsibility

35% · 247 points▾

PeopleLevel 4 of 5
115 of 144 points
High level of responsibility for people. The job involves significant responsibility for the well-being and development of others. This includes making decisions that affect others' jobs, tasks or welfare, such as managing teams, providing care, teaching or ensuring psychological safety. It can also include hiring, evaluating, motivating, coaching and leading workers.
Goods and equipmentLevel 1 of 5
17 of 84 points
Limited responsibility for goods or equipment. The job involves the care and proper use of low-value tools or materials, with minimal responsibility for their maintenance or security.
InformationLevel 4 of 5
77 of 96 points
Considerable responsibility for information. The job manages large amounts of valuable or sensitive information, deciding what is needed and how it is used and ensuring it is protected.
Financial resourcesLevel 2 of 5
38 of 96 points
Limited responsibility for financial resources. The job involves handling limited financial resources, such as managing small budgets, processing invoices or participating in financial planning discussions.

Effort

15% · 91 points▾

Mental effortLevel 4 of 5
48 of 60 points
Very high level of mental effort. The job requires continuous high-level mental concentration, with few or no breaks, involving intellectually demanding tasks that require continuous focus.
Psychosocial and emotional effortLevel 3 of 5
43 of 72 points
Moderate psychosocial and emotional effort. The job requires the regular management of emotional responses, such as dealing with sensitive or challenging individuals or situations.
Physical effortLevel 0 of 5
0 of 48 points
Not applicable. The job does not require any physical effort.

Working Conditions

10% · 24 points▾

Environment (physical, psychological or emotional)Level 1 of 5
17 of 84 points
Minimal exposure to hazards or stress. The job involves little or no exposure to physical hazards (e.g. chemicals, moving equipment, noise) and minimal emotional or psychological risks (e.g. occasional routine tasks with no emotional burden). There is minor exposure to dust, dirt, fumes, noise, waste, poor lighting, etc.
Organisational environmentLevel 1 of 5
7 of 36 points
Minimal organisational demands. The job requires standard working hours with no night shifts or irregular schedules. There is little or no need for travel or digital connectivity beyond typical working hours.