Our client is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients. Their team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are right from the project outset to support Their client’s global business. People are at the heart of their family-owned business and their values guide the way to their success. Team spirit and mutual support are very important to them. their culture is characterised by strong international co-operation, can-do attitude, focus on quality and a growth mindset.
their strength is to be where it matters - think globally, act locally!
This role can be based in Europe, the United States or the United Kingdom. The Group Leader will help build and establish a global, expanding team to support a diverse set of clients globally in their regulatory compliance initiatives for food & food contact materials. This position is accountable for all aspects of complex Regulatory Affairs projects from inception to conclusion, including capacity planning, budgeting and the day-to-day operations of the team. The Group Leader will report to the Head of Division, Food & Food Contact Materials.
YOUR TASKS
Technical & People Leadership:
Act as an expert for food & food contact materials regulatory projects based upon international regulatory frameworks
Manage food contact regulatory projects from first client contact to project completion, in order to ensure delivery of projects and quality reports on time to knoell Clients
Provide regulatory consulting advice to clients and knoell colleagues by utilizing their global regulatory knowledge and experience in the food and food contact service area.
Conduct technical reviews of regulatory compliance assessments and provide regulatory guidance and interpretation based upon existing food and/or food contact regulations
Works to set standards with the goal of improving work performance and organizational communication
Manage staff (communication, motivation, feedback, conflict management, performance appraisals)
On-board, mentor, train and develop staff; ensure own training and development
Plan resources; propose hires (and terminations); participate in job interviews in conjunction with other knoell stakeholders
Budgeting & Capacity Utilization:
Budget planning together with the global and finance leaders
Capacity Management of all global direct reports (five)
Utilize staff efficiently to maximize project profitability without sacrificing quality
Monitor and optimize the capacities and workloads of the team, in collaboration with global leaders
Ensure project profitability
Lead and steer the integration of new regulatory experts into global knoell projects
Business Development & Proposals:
Responsible for maintaining and expanding the revenue of an existing book of business
Retain, maintain and expand existing clients
Network with existing and potential clients
Monitor customers/needs/trends, and communicate with the Head of Division
Responsible for working with client and proposal authors within the FFCM Team to prepare proposals in a timely manner
Responsible for cooperating with the proposal support team, project managers, and Head of Division
Project Oversight:
Ultimately responsible for a client’s satisfaction and ensuring that the final regulatory product is in accordance with the client’s specifications as described in the project proposal
Organize project resources, including assembling, coordinating and managing multidisciplinary technical teams, including those in the Departments
Manage project budgets, and capacities
Analyze project success together with project controlling and Business Unit Leaders
Provide regulatory expertise where needed for project success
Provide excellent and timely communication with knoell team members, clients and regulatory authorities
Maintain sense of urgency around projects and deliverables
Ensure timeliness and quality of deliverables
Identify project problems and corrective solutions
Bachelors degree required in a scientific discipline. Advanced degree (MS/PhD) or certification a plus.
At least 5 years professional experience in the compliance and/or authorization of food and/or food contact materials in the national or international regulatory context
Direct supervisory experience preferred
Project management experience or certification (eg., 6 Sigma, PMI) a plus
Working knowledge of US FDA regulations, EU regulations and/or other global regulations for food and food contact as it relates to the compliance and notification process
Experience working with clients as part of a consulting company and/or experience working with suppliers
Extensive experience managing teams and projects
Demonstrated excellent attention to detail, organizational skills and ability to prioritize work
Excellent communication, organization and presentation skills
Excellent language skills in English (spoken and written); additional language skills would be an asset
Ability to work as a key member of global team
Their are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Our client is a drug-free workplace. As a condition of employment, new hires may be required to pass a pre-employment drug test.
The company complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities.
We look forward to receiving your application!