Job Summary
The Regulatory Affairs Officer has ensure the regulatory compliance for all our client’s consumer products (regulated e.g. as cosmetics, medicinal products, medical devices) for all countries in the Management Unit CEWA.
He/she combines his/her knowledge about scientific, legal/regulatory and business aspects to ensure compliance to relevant legislation.
He/she advises on and coordinate the approval, registration, listing or notification of our client’s consumer products to ensure fast access to market in the CEWA countries.
Primary Responsibilities
Development of MU QMS
On shelf assessments and reporting of results to relevant stakeholders
Management of VAS activities and LSP to include monitoring of warehousing of products from other countries.
Any other responsibility and duties as may be necessary
Qualifications And Experience
The minimum necessary qualification is a university degree in sciences (chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science).
Alternatively a solid track record of experience in regulatory affairs may be acceptable to qualify as Regulatory Affairs Officer.
Continuing education and professional development are critical to the Regulatory Affairs Officer. He/she must keep up to date with regulatory policies and procedures for the countries in his responsibility as well as maintain an understanding of the scientific and technical background of the company´s products.
Competencies
Project management, organization, negotiation
Strong communication skills.
Analytical and problem solving skills
The ability to learn from the experience of others, both inside and outside the organization.
The ability to work efficiently with internal and external stakeholders
English language (fluent in writing and speaking); as the communication flow to corporate functions is of crucial importance
