Regulatory Affairs Specialists

Legal & Corporate Governance

Level 5481 of 1200 points

Job description

Regulatory Affairs Specialists

Job purpose

To coordinate and document the organisation's regulatory processes and to prepare and review regulatory submissions and technical files for domestic and international projects, so that products obtain and retain approval and the organisation operates within current regulations and standards.

Skills

Detailed specialist knowledge of laws, agency rules, guidance documents and international or consensus standards applying to the organisation's products, including premarket, export and labelling requirements and clinical study compliance; enough of the underlying biological science to give technical review of data; and a precise command of written English. Bachelor's degree is the norm, with a minority holding a master's degree or post-doctoral training, together with several years of related experience and on-the-job training.
Communicates with regulatory agencies on pre-submission strategies, regulatory pathways, test requirements and clarification of submissions under review, and assists governmental inspectors before, during and after inspection. Advises project teams on premarket, export, labelling and clinical compliance questions, interprets rule changes into corporate policy, and delivers employee regulatory training.
Determines which submissions or internal documentation a proposed device or labelling change requires, identifies the guidance and consensus standards that apply, and judges whether data, promotional material, labelling, batch records and test methods meet them. Coordinates recall or market withdrawal activity and recommends adjudication of complaints. Problems require the construction of rules open to interpretation, often on incomplete information.
Coordinates submission preparation across domestic and international projects against agency timetables, maintains technical files and documentation databases, writes and updates standard operating procedures, and tracks quality metrics. Largely determines own priorities, with external deadlines setting the pace.
Work is carried out at a desk and in meetings and inspections, using computers and document management systems, with sustained keyboard and repetitive hand use.

Responsibilities

No line management. Coordinates and leads contributors across project, clinical and production teams in assembling submissions and the further information agencies request. Conducts regulatory training for employees and advises managers and project teams as the recognised source of regulatory judgement.
No budget held and no authority to commit expenditure. Influence is indirect: submission strategy determines approval timetables, and recommendations on recall or market withdrawal bear on co-workers and on company results.
Ordinary care of a workstation and of the regulatory documentation systems maintained. Directs the collection and preparation of laboratory samples requested by agencies, and determines requirements applying to the storage, shipment or disposal of potentially hazardous production waste, without custody of plant or stock.
Accountable for the regulatory record: technical files sustaining product approval, submissions and agency correspondence, adverse drug reaction reports and audit documentation. Content and structure are set by agency requirements rather than by the organisation, exactness is critical, and decisions on this material affect co-workers and company results.

Effort required

Sustained close reading and cross-checking of regulations, guidance, clinical protocols, labelling, batch records and technical data, where being exact and accurate is central and scientific rigour must be assured. Judgement is exercised on unsettled regulatory positions, and decisions are taken frequently and under the time pressure of agency deadlines, alongside a high volume of contact by e-mail, telephone and face-to-face discussion.
Carries personal accountability for the accuracy of what the organisation states to regulatory agencies and for advice on which project teams rely, explaining that position to inspectors and reviewers, and doing so under recurrent time pressure.
Almost entirely seated work at a desk, with repetitive hand and keyboard motions. No lifting or exertion.

Working conditions

Indoors in an environmentally controlled office throughout, in close physical proximity to colleagues in shared workspace and meetings. No exposure to hazardous conditions or equipment, contaminants, noise or outdoor weather, and no dealings with hostile people. The demand is a high volume of contact with agencies, colleagues and external parties, and accountability for accuracy.
Most incumbents work a regular established schedule; a little over half work a standard week and the remainder longer. Time pressure attaches to submission and inspection deadlines, and decisions are made frequently, with impact on co-workers and company results. Operates with considerable freedom to determine tasks, priorities and goals, bounded by regulatory requirements and corporate policy rather than close supervision.

Skills

40% · 249 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 3 of 5
58 of 96 points
Effective communication and interpersonal relationships. The job holder is required to adapt communication to different audiences and foster trust, cooperation and positive working relationships.
Problem-solving skillsLevel 3 of 5
58 of 96 points
Variable problems. The job involves dealing with different kinds of problems that require careful thinking, research into different options or adjusting existing ways of doing things. Guidance and resources may be limited.
Planning and organisational skillsLevel 3 of 5
43 of 72 points
Moderate organisational skills required. The job requires the organising and prioritising of multiple tasks, with some level of adjustment to plans on the basis of changing circumstances or deadlines.
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% · 133 points▾

PeopleLevel 2 of 5
58 of 144 points
Basic responsibility for people. Provides support, guidance or advice to individuals or small teams. This could include assisting with personal development, providing informal mentoring or guiding others through tasks with minimal decision-making power. It may involve contributing to others' sense of safety and comfort, but with limited decision-making authority or accountability for outcomes.
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 3 of 5
58 of 96 points
Moderate responsibility for information. The job involves managing information to ensure it is accurate, of high quality and secure. The job holder may make decisions about the handling of sensitive data.
Financial resourcesLevel 0 of 5
0 of 96 points
Not applicable. The job does not require any responsibility for financial resources.

Effort

15% · 75 points▾

Mental effortLevel 3 of 5
36 of 60 points
High level of mental effort. The job involves frequent concentration on complex tasks that require considerable mental effort, such as interpreting complex data.
Psychosocial and emotional effortLevel 2 of 5
29 of 72 points
Occasional psychosocial and emotional effort. The job requires occasional involvement in emotionally demanding situations, such as handling minor conflicts or dealing with upset individuals.
Physical effortLevel 1 of 5
10 of 48 points
Minimal physical effort. The job involves light physical tasks, such as occasional lifting or moving light objects.

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.