Job Search

PURPOSE OF JOB

To be responsible for operational direction of the Regulatory Affairs function whilst supporting the strategic developments for new product development, product registration and Product Information File. It is the job holder's responsibility for ensuring that products within all product categories are in compliance with the relevant market regulations. 

Scope of Job

This position reports directly to the Regulatory and Technical Affairs Director and will be a member of the management team of Regulatory and Technical Affairs department.  The job holder will manage a team of scientists. There will be daily contact with other managers and directors and other personnel within R&D, Marketing and other departments, regulatory authorities world-wide and supplying companies of finished products. The job will involve some foreign travel. The job holder will be the expert in the regulations affecting the Company's business.

KEY RESULTS AREAS

1 Manage Regulatory Affairs Section

- Provide managerial support to the two teams in Regulatory Affairs i.e. NPD and Markets.

- Ensure that the Regulatory Affairs Section is run efficiently, provides the expected level of service, has sufficient resource and maintains agreed budget levels of expenditure.

- Reviews regularly with direct reports the progress and status of projects and provide advice and support as required.

- Create, review and help implement individual development plans for direct reports and their staff.

- Report regularly on the activities of the section and provide monthly reports on time with effective KPI's to the Regulatory and Technical Affairs Director.     

2 Develop and Maintain Knowledge and Expertise on Regulations affecting the Company's Business

- Develop an in-depth knowledge of International regulations and specific implications in key markets and new market entries.

- Keep up to date with regional market regulations and develop a solid understanding of these regulations.

- Anticipate new or changing regulatory requirements in relevant territories.

- Inform the appropriate people of changes to regulations and their implications to the business whilst applying smart business practices to the recommendations.

- Be the expert in the regulations affecting the Company's business.   

3 New Product Development (NPD)

-Ensure that the NPD regulatory team provides a good professional service so that all products placed in the markets are in compliance with the market regulations.

- Provide the regulatory NPD manager with the necessary labeling requirements to satisfy all markets. 

- Provide strategic support to the supply team on the label variant strategy

4 Support to the Company's Sales Companies

- Provide accurate and timely regulatory support to sales companies particularly to start up companies and companies experiencing changes to their regulations

- Foster and develop constructive and professional working relationships with the Company's personnel in the sales markets.

- Meet and develop relationships with the competent authorities and influence them on the Company's developments and compliance with market regulations.

- Facilitate Regulatory Fora with the key markets to ensure that we adopt best practices and share relevant information on important developments within the global regulatory environment.

- Develop, adopt and execute robust, smart business processes to optimise product registration lead-times within our sales companies

5 Product Information

- Ensure that the requirements of the Product Information File are kept up to date and stored in an accessible manner for inspection.

- Work with the product safety manager to ensure that all products are formulated in line with highest industry standards and meet the requirements of key International regulations.   

-   Communicate Regulatory Policies and Requirements to the relevant purchasing teams so that competent suppliers are selected for product manufacture.

6 Industry Representation    

- Represent the Company and business interests at Trade Association meetings or task groups as required and agreed on regulatory matters.

- Represent the Company in negotiations and discussions with the key industry and competent authorities as required.

QUALIFICATIONS

A recognised Science qualification with a minimum of 5 years relevant experience within the Cosmetic Industry or related industries (pharmaceutical or food sectors).

COMPETENCIES

•Extensive working knowledge of cosmetics industry and regulatory environment from a global perspective.

•Well developed communication skills with the ability to communicate effectively both internally and externally with European industry bodies and global competent authorities.

•Have a good understanding of the legal framework and practical implications in the implementation of the relevant regulations.  

Contact AHMED BOURGHIDA @ SIGMAR RECRUITMENT, (01) 2344144

Or send CV in strictest confidence to ahmed@sigmar.ie

Your details will not be submitted for this or any other role without your expressed permission