EMPLEO : Regulatory Affairs Coordinator LATAM-Region – Oprandi & partner
Our customer is a global acting and top ranked live science company with European head quarters located in Basel/Switzerland. To maintain its leading position in the health care market a continue development of the medicine and the associated monitoring technologies for patients/consumer is evident. The International Regulatory organization (IRA) is responsible for the registration, licensing, labelling and marking processes for the consumer care market. Therefore we are looking for a highly motivated
Regulatory Affairs Coordinator LATAM-Region
Position purpose: LATAM-Region Coordinator within International Regulatory Affairs (IRA) is primarily responsible for ensuring that company regulatory activities and needs are aligned with product supply activity in the Latin American region. In addition, you are providing general regulatory support to regional affiliates while monitoring and reporting on legislative and policy developments in the region. This helps to ensure that registration documents are relevant and up-to-date and that manufacturing activities effectively support regulatory requirements in countries where products are registered. This alignment of manufacturing and regulatory activity optimizes costs and timelines, resulting in faster time to market and realization of company’s commercial objectives.
Your responsibility: Acting as the primary regulatory contact with company local affiliates in the region, providing regulatory leadership to countries in the region and maintaining an understanding of the supply chain capabilities and issues in the region. You are remaining up-to-date on legislative/policy development in the region, acting as a liaison with IRA Lead, Regulatory Strategists and Associates to ensure that product supply capabilities/issues are appropriately reflected in dossiers.
You are maintaining an understanding of regulatory requirements as they relate to regional supply chain activities, helping product supply ensure that manufacturing sites are knowledgeable of and activities are in line with regulatory requirements. You are coordinating, monitoring, and reporting on plant transfer activities and coordinating regional registration issues as well as labeling compliance.
Your personality: You hold an university degree in Life Sciences, a post-graduate degree in business administration is preferred. You provide significant experience conducting regulatory-related business in the LATAM-Region; you have 2 to 5 years of experience in a comparable position or 7-10 years of experience in a regulatory or product supply role. You provide experience in regulatory functions related to initial applications, variations and renewals. You are able to establish strong relationships across different functions and cultures and to communicate effectively in English and Spanish both verbally and in writing. Important is your willingness to travel (up to 40%).
Your perspectives: You have the opportunity to work in an open, dynamic and very motivated environment with the chance to grow in your career and become a key member in the regulatory organization.
If you are interested in this challenging position please send us your application to the below mentioned e-mail address.
Rinaldo Bearth, oprandi & partner ag, personnel recruitment, Birsigstrasse 50, CH-4054 Basel Telephone +41 61 228 97 93, e-mail: bearth@oprandi.ch, www.oprandi.ch
oprandi & partner is an international group of companies with numerous subsidiaries in Europe and the UAE/Dubai