Global Regulatory Affairs Manager
KEVIN.MURPHY is a fast-growing manufacturer and distributor of high-end hair care products that are sold in professional salons throughout the world. We are in search of a full-time Global Regulatory Affairs Manager.
Reporting to the Global Director of Procurement, the Global Regulatory Affairs Manager will be responsible for leading activities of the Regulatory Affairs Department with an emphasis on global regulatory strategy and the preparation, review and submission of documents to any regulatory authorities at a Global level.
Requirements and Responsibilities
Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions in the geographical areas where KEVIN.MURPHY Group products are marketed. Coordinates inspection of the organization and contract facilities and develops procedures to ensure regulatory compliance. Requires a Master's degree in the area of specialty. Typically reports to top management. Collaborates with the Global Director of Procurement in managing subordinate staff in the day-to-day, annual reviews, other personnel actions, disciplinary actions and performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Extensive knowledge of department processes.
- Provide responses to regulatory agencies regarding product information or issues
- Train staff in regulatory policies or procedures
- Develop and maintain Standard Operating Procedures (SOP) for the Regulatory Affairs Department. In cooperation with the quality department, oversee compliance to ensure compliance with applicable standards and regulations.
- Establish regulatory priorities and/or budgets and allocate resources and workloads
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Provide regulatory guidance to internal departments or development project teams regarding design, development, evaluation, or marketing of products. Communicate regulatory information to multiple internal departments and ensure that information is interpreted correctly.
- Develop regulatory strategies in collaboration with the Global Director of Procurement and implementation plans for the preparation and submission of new products
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. To ensure Safety Data Sheets (SDS) are up to date and in line with current regulations for all products within KEVIN.MURPHY.
- Review materials such as marketing literature, artwork or user manuals to ensure that regulatory agency requirements are met
- Develop relationships with global environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Evaluate regulatory affairs aspects that are specifically environmental, such as the use of toxic substances in packaging, carbon foot printing issues, or green policy implementation.
- Work with quality department to prepare for and facilitate inspections and audits by regulatory agencies and/or clients. Help to investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Oversees maintenance of technical files, Medical Device Directive(MDD) certifications and declarations of conformity(CoC) and Certificate of Analysis (CoA) in support of EU product registrations.
- Work with manufacturers, if necessary, on non-conformity with appropriate regulations and documentation.
- Seven (7) to ten (10) years’ experience as a Global Regulatory Affairs Manager, or similar background
- Proven experience of developing and implementing regulatory plans; promotion and labeling requirements; commercialization and operations
- Act as a company expert on EU Regulatory in the concerned areas
- Analytical skills with the ability to interpret information and its practical application.
- Strong project management skills, ability to multi-task and meet deadlines
- Knowledge of packaging components and raw materials used in the beauty/personal care industry
- In-depth knowledge and understanding of FDA guidelines, US federal regulations and International regulations as they relate to raw materials, formulations, packaging and labeling compliance of beauty care and cosmetics products
- Five (5) or more years of supervisory experience, required
- Must be able to travel up to 25% of the time
- Masters’ degree in the technical field(s) of chemistry, pharmacology, food, biological/ physical science; or more general areas such as (international) law, or another related field
- Minimum seven (7) years of regulatory experience with a beauty care/cosmetics company
- Fluency in spoken and written English.
KEVIN.MURPHY is a fashion focused range of salon-only, professional hair care products created by Kevin to meet his needs as an editorial hairstylist. Also, under the KEVIN.MURPHY brand COLOR.ME, which was born from KEVIN.MURPHY's vision of fusing session work, fashion lies and hair colour. This is an amazing opportunity for a professional who is serious about their work and this industry. If this sounds like you, and you want to join our team, please see the application instructions below.
The position is based at our European office at Refshaleøen in Copenhagen, Denmark.
Application: Please send cover letter and resume with salary requirements to email@example.com. Deadline for applying for the position is 25 May 2018.