Head of Regulatory Affairs

Join Exeltis!

We are looking for a Head of Regulatory Affairs with solid experience in the management and compliance of sanitary requirements for regulated products, capable of leading regulatory strategies and coordinating procedures with the corresponding authorities.

Main Responsibilities

• Lead the strategy and operation of the Regulatory Affairs area.
• Manage procedures and regulatory compliance related to controlled drugs, food supplements, and medical devices.
• Coordinate and track import permits and authorizations.
• Manage procedures related to advertising and promotion of regulated products.
• Prepare, review, and keep up-to-date regulatory files and documentation.
• Track registrations, permits, notices, modifications, and renewals with the health authorities.
• Evaluate the regulatory impact of new products, promotional materials, and changes to existing products.
• Advise the Commercial, Marketing, Purchasing, Importation, and Management areas on regulatory requirements and risks.
• Maintain permanent vigilance over changes in applicable legislation, norms, and sanitary provisions.
• Coordinate audits, verification visits, and requests from the authorities.
• Supervise and develop the Regulatory Affairs team.

Required Profile

• Degree in QFB, QFI, IF or related field.
• 6 years of experience in Regulatory Affairs within the pharmaceutical, medical device, food supplement, or related products industry.
• Proven experience with controlled drugs.
• Experience in import permits and sanitary procedures.
• Knowledge and experience in regulation of advertising for health products.
• Experience in managing procedures with health authorities.
• Ability to interpret legislation and regulatory requirements and convert them into concrete actions for the business.
• Leadership, organization, negotiation, and communication skills.
• ADVANCED English

⭐ We Offer

• Competitive salary in line with experience.
• Benefits above those required by law.
• Strategic participation in high-impact regulatory projects.

If you have experience in controlled drugs, food supplements, medical devices, importations, and sanitary advertising, we want to meet you.

Send your CV