Global Regulatory Affairs Director
As a global organisation our client are able to offer exceptional career development opportunities all around the world and as such we are currently seeking an Global Regulatory Affairs DIrector to work within our UK Quality, Regulatory and Compliance / Global Regulatory Affairs Team.
You will provide vision, leadership, direction and management in the implementation of regulatory policies, procedures and strategies to ensure regional/domestic and global regulatory compliance of products and ingredients used in the manufacture of these products.
You will strategise with, communicate and advise along with providing vision and direction to consumer business teams and senior leadership concerning global market entry strategies and tactics, product lifecycle management regulatory compliance activities as well as growth opportunities for existing categories within a regulatory framework that focuses on compliance.
Your primary customers are the Family Care businesses. Additional customers are Professional and Corporate Innovation business units including their respective management teams as well as regional and sector business leaders and teams. Internal customers also include mill/plant operations and quality management teams, business quality teams, R&E, Legal, Corporate Security, Corporate Communications, the Supply Chain teams including Global Quality Assurance, Global Product Safety, Procurement, Purchasing, Logistics, Product Supply and Environmental and Sustainability teams. External customers include key opinion leaders, suppliers and contract manufacturers.
Expectations and Accountabilities :
You will lead your respective GRA teams, responsible for providing regulatory strategies, preparation of regulatory submissions and registration services to enable business units to achieve their objectives while ensuring that each business complies with applicable regulatory standards and requirements.
In terms of scope, you will provide leadership, coordination and development of a global centre of excellence within GRA and across the Enterprise. You will lead the development and implementation of the critical programs and processes necessary to ensure domestic and global regulatory compliance across the EMEA region. A major challenge of this position is to provide vision to ensure R&E / Business Unit platforms, programs and innovation activities focus on current and future regulatory compliance requirements. You will also provide protection to technologies and products through the application of product sustainability programs.
In addition, you will:
- Ensure that all elements of the Corporate Code of Conduct are fully supported;
- Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported;
- Manage teams and self in accordance with the behaviours and leadership qualities associated with this role;
- Prepare and implement unit budgets and schedules and implement appropriate controls as required;
- Execute all regulatory activities in accordance with Corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.
- Communicate appropriately with all customers, conducting all communications and transactions with the utmost integrity and honesty so as to build an unimpeachable business reputation.
- Interpret and communicate current national, regional and global regulations applicable to EMEA that cover a broad product range including medical devices, biocides, cosmetics, consumer products, food contact products, electrical products, toys; identify and communicate the impact of the regulations to the relevant business units;
- Anticipate, monitor and influence changing EMEA regulatory requirements applicable to all major product categories, including through active participation at relevant trade associations;
- Determine applicability of new or proposed changes to EMEA regulations on marketed products and the innovation pipeline, communicating these developments to senior business leaders and platform managers;
- Prepare regulatory submissions, registrations, notifications, certifications in accordance with national and regional regulatory requirements to facilitate global market expansion in accordance with business launch plans; devise and implement strategies, processes and procedures to ensure that products comply with local regulatory requirements within EMEA at the time of commercialization and throughout the product lifecycle;
- Review and revise Enterprise regulatory policies and standards on a regular basis;
- Serve as official correspondent with EU designated medical device, cosmetic and consumer regulatory agencies as well as with applicable Notified Bodies;
- Assist the Director GRA in developing product regulatory market entry strategies for new innovations and technology;
- Leverage global consulting network to provide targeted expertise for concepts and new product development requirements; communicate these to the requisite business/project teams and utilize this network to facilitate global market expansion;
- Build knowledge bank and make available a single source of global regulatory requirements for the various product categories commercialized by business units providing transparency to the level of regulatory complexity for senior business leaders;
- Provide leadership and advice on complaint handling, adverse event reporting requirements and EMEA post-market surveillance requirements;
- Evaluate information provided by businesses on adverse events and execute requisite reporting to regulatory agencies;
- Review and approve business unit recall strategies and implement recall activities with national and regional regulatory agencies;
- Review risk mitigation plans and monitor ongoing results;
- Represent Regulatory Affairs on crisis management teams;
- Ensure regulatory accuracy of corporate communications concerning crisis situations and other social media activities;
- Conduct due diligence for partnerships, mergers, acquisitions, licensees, etc.;
- Provide advice concerning external regulatory inspections and provide subject matter expertise to formulate audit strategies;
- Actively participate in the regulatory component of product stewardship activities with appropriate participation on the Product Stewardship Council;
- Coordinate global/regional registration activities with regional/local regulatory teams as the lead interface with global/regional product development teams;
- Develop and execute regulatory strategies that will ensure compliance with global, regional and national chemical regulations and reporting requirements such as REACh and SVHC mandates;
- Develop and execute regulatory strategies that will ensure compliance with EMEA regional and national regulations concerning hazardous goods transportation and globally harmonized standards;
- Perform other tasks and activities as directed by the Director GRA.
Qualifications/Education/Experience Required :
To be considered for this role you will need;
- This role is available for local candidates already authorised to work in the roles country only.
- Bachelor’s degree in a science, engineering or related discipline or equivalent
- Sufficient experience within a senior level role to achieve the role objectives
- Evidence to show a solid background of technical knowledge and experience in regulatory affairs
- A proven ability to successfully direct projects
- The ability to demonstrate successfully influencing people at all organizational levels
- Experience in driving decision making
- Experience of effectively and efficiently managing a large financial budget
Experience of successfully managing direct reports
This job has now been successfully concluded.