Company: Mosaic Regulatory Solutions
Closing Date: 11 Feb 17
Salary (£): On Application
To apply for this regulatory affairs manager role please call Julie Cooper on 07951 082482 or send your CV to: Julie@mosaicrecruitment.co.uk
Job Title: Regulatory Manager
Location - Belgium ( Ghent )
· Independent portfolio leadership with minimal direction (e.g. within category, product type, territory, technical speciality)
· Predominant focus on NPD / Business Development projects rather than life cycle maintenance
· Contribute beyond product projects to functional change projects, seeking opportunities to lead improvements in the team
· People / Team leadership and development
Please attach organizational chart and indicate the number of reporting relationships.
Up to 3
(unless pursuing a purely technical career)
Potential for in-directs
List the 4 to 8 major duties/responsibilities of the job. Do not list all of the individual tasks or steps that are performed. State the approximate percentage of time spent on each major duty in a given year.
Major Duties and Responsibilities
% of Time
Ensure compliance with appropriate global legislation governing Safety Surveillance, Manufacturing and Distribution of products, resulting in no interruption to flow of business or impact on company reputation.
Work in close partnership with the cross functional team, being a trusted partner in NPD strategy. Work to increase external network in the regulatory community.
For International: Support the affiliate regulatory teams to find creative ways to influence their local Competent Authorities to ensure product success.
For Affiliate: Work with International Reg to ensure country expertise is considered in evolving regulatory strategy.
Maintain a level of expertise which significantly contributes to growth in the business, within the portfolio they are accountable for (e.g. category, product type, territory, technical speciality). Where leading a team, leverage this team to deliver the regulatory actions needed to get products to market and keep them there with optimised positioning versus the business strategy. Take minimal direction from senior leaders to achieve their goals. Ensure our company are synonymous with world-class regulatory documentation and influencing capability, to ensure regulatory aspects are never a barrier to our commercial goals. Be a trusted voice in the innovation / NPD process to ensure all opportunities are optimised and we have an appropriate balance of risk vs. return within the pipeline.
Inspire each other
Coach and develop the organisation so that individuals develop industry leading talent which gives a significant competitive advantage. Where leading a team, manage the training and personal development of all members of the team.
Matrix Relationships and Scope: If applicable, describe the extent to which this job has a dual (or matrix) reporting relationship, where it reports directly to one manager (possibly the head of a production facility or geographic location), and also to another manager (such as the head of a function, like finance or information technology).
Describe the nature and variety of the most typical and the most complex problems this job must resolve.
· Predicting and reacting to changes in the external regulations
· Regulatory strategy development to achieve the commercial goals
· Budget management
· General people management issues inc. retaining top talent
Most Complex Problems
· Regulatory / Competent Authority refusal to approve = no launch or interrupted supply
· Understanding and overcoming the legal and regulatory interpretation of healthcare product legislation, guidelines and established practice
· Prioritising within the commercial goals to ensure resources are deployed to the highest potential projects
Decision Making Authority and Responsibility
Identify the types of decisions that this job has the authority to make on its own as well as those that must be referred to others. In both cases, include authority for decisions regarding issues of policy and procedure, administrative matters, and personnel (hiring, firing, salary increases, etc.).
Type of Control
What typical decisions does the job have total authority for making?
· Decisions on project expenditure within the framework of agreed budgets and strategy, inclusive of outsource decisions
· Regulatory executional steps / actions to deliver an agreed strategy
· Regulatory strategy recommendations to the Exec Team
· Project prioritisation within accountable portfolio
· In our regulatory dossiers and negotiations, any trade-offs / compromises to gain approval, and tactics for influencing Regulatory Authorities
What typical decisions are referred to others for approval?
· Decisions on project expenditure outside the framework of agreed budget and strategy
· Project prioritisation and resource utilisation within broader functional group
Provide financial dimensions about the position that will best describe or measure its size, influence, or effect on the business. Think in terms of items/areas that the job must manage, control, influence, or impact in a measurable way. Enter “not applicable” if the financial impact of the job cannot be determined.
List the financial dimension in the first column, the associated dollar amount in the second column, and in the last column indicate whether the position has “Individual” control of this dimension, whether it “Shares” in making final decisions as part of a group, or if it “Advises” those who make the final decision concerning this dimension.
Example financial dimensions: operating/department budget, annual payroll of supervised employees, sales revenue, capital expenditures, production costs, advertising expense.
Type of Control
Specific role dependant – will include accountability for regulatory spend within particular portfolio and where leading a team it will include the annual payroll of that team. In D5 role will have ability to influence a larger financial target than D4 e.g. international role vs. affiliate role
ADDITIONAL INFORMATION: List any information not included in the previous answers that is important to know about the position.
The job holder will:
· Ensure full personal compliance with Company Codes of Conduct
· Drive the teams under his/her consultation to achieve the necessary standards of technical service, product quality, efficiency, training, documentation, quality and compliance. It is vital this is done in a manner which is inclusive, provides appropriate delegated authority and in a fair and consistent style so as to engender a committed team approach
· Ensure appropriate reporting through the business to enable appropriate tactical and strategic decisions to be made to protect, enhance and develop the business
· Spend sufficient time at the sites relevant to their role, to be able to develop and maintain understanding of the processes and people, communications/relationships
· Have a thorough understanding of the legal and technical framework within which we operate. The job holder will be representing the company externally and, where appropriate, will contribute to the company’s influence and reaction to media, customer, competitor communications in conjunction with the Executive Team and/or colleagues
Person Specification and Competencies
Knowledge and Experience: What is the minimum level of knowledge (e.g., theories, principle, concepts, etc.) and skills that are necessary to competently perform the job (include formal education or equivalent, type and years of prior work experience, and other qualifications)?
· Min. 7 years regulatory experience or other relevant function
· May be specialist in one product type e.g. OTC Medicines, VMS, Medical Devices, Cosmetics
· Detailed understanding of the workings of and key stakeholders in Global Competent Authorities
· Current awareness of legal framework and forthcoming legislation that will affect the business
· People management / team leadership experience desired but not essential – can be first people leadership role with appropriate training put in place
· Strong overall leadership skills with excellence in coaching, negotiation, strategic thinking, prioritisation and effective delegation
Standard Operating Procedures
The job holder has specific responsibilities detailed in the following Standard Operating Procedures (SOPs). The SOPs are referred to in the Company Quality Manual. This and controlled copies of all SOPs are available for inspection at all Quality stations throughout the Company.
The job holder is responsible for ensuring that they work in accordance with these SOPs
There are a significant number of SOPs related to this role so they are not listed here but are captured in the QMS Training Matrices
Essential Training Requirements Revisions
Additional SOPs and Training Requirements that are relevant to the job holder will be brought to their attention and records of training held. These requirements will be added to the job descriptions at the next review
In compliance with the Perrigo Safety Policy and Procedures, to ensure a health and safety culture is supported in the areas for which the job holder is responsible. This will be achieved through objectives, motivation, education and training, and ensuring that any team member not complying with safety performance standards is dealt with appropriately. The job holder will set a personal example in relation to safety practice and ensuring that reporting staff are adequately trained for the task they are asked to undertake, including use of control measures and PPE
Key word / Key words- regulatory affairs , reg affairs manager , regulatory , medical devices , cosmetics , OTC , VMS , Belgium
Mosaic Regulatory Solutions Ltd
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