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Job Description

The Global Regulatory Life Cycle Management Team has a fulltime position available to grow part of our global Digestive Brands in particular for the LATAM region. We need a candidate who will coordinate, from regulatory perspective, projects related to new initiatives requiring changes to existing products/dossiers, roll-out of existing dossiers to white space and day to day changes to our products keeping them on the market.

This opportunity will see you act as the regulatory representative for specific global or regional initiatives within the Digestive Brands Franchise and as a regulatory business partner for any other of our products franchises projects as needed. This position will act as point of contact for our local regulatory colleagues, who manage local markets and authority interactions, as well as with other technical functions, Product Supply, Quality Assurance and manufacturing sites.

Key Responsibilities:

• Coordinate Regulatory Life Cycle Management activities within Digestive Brands Franchise.

• Coordinate with Local Regulatory Affairs for roll outs (expansions to white space), variations, renewals and answering health authority requests.

• Coordinate as RA SPOC all regional and global projects related with his/her products of responsibility. Elaborate and implement regulatory assessments to support those projects requirements and assure portfolio in place.

• Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve registrations for the specific product portfolio.

• Ensure regulatory assessments are conducted for change controls in the respective Quality tracking system.

• Advise organization of potential regulatory risks in normal day to day activities and proactively recommend the regulatory mitigation actions required.

• Provide Regulatory input for Periodic Safety Update Reports (PSURs), Periodic Quality Reports (PQRs), and Product Data Sheets (PDS).

• Liaise with Corporate Technical and Product Supply functions to provide the current registered details.

• Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.

• Provide regulatory input into Global Product labelling and approval to enable commercial activation of product launches in compliance with local market regulations.

Job Qualifications

• A minimum of Scientific bachelor’s degree in Life-Science (pharmacy, medicine, chemistry, biology, etc.).

• Proficiency in English, Spanish.

• Regulatory experience (1-3 years) preferably in consumer health and preferably across multiple regulatory classification areas (food supplements, medicines, medical devices, etc.)

• Some experience in maintenance of existing products licenses across one or, ideally, more than one different Latin America countries.

• Some experience in developing regulatory strategies for successful launches of new products.

• Demonstrated ability to work independently in a matrix environment to build superior relationships with stakeholders.

• Strong initiative and follow-through with accountability for work quality.

• Excellent attention to detail, communication and presentation skills.

• Results oriented and self-motivating with an ability to influence others.

• Demonstrated ability to handle competing priorities effectively with excellent organizational skills.

• Commercial understanding of corporate and operational business issues.

• Openness to change and ability to think out of the box.

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