HEAD OF REGULATORY AFFAIRS

Job Title: Head of Regulatory RegistrationsLocation: Barcelona, SpainDepartment: Regulatory AffairsReports to: Global Director of Regulatory AffairsRegions: LATAM, APAC, EMEA, ASEAN, and other international marketsJob Overview:The Head of Regulatory Registrations will be responsible for leading and managing the global regulatory registration activities across multiple regions, including LATAM, APAC, EMEA, ASEAN, and others. This role requires an in-depth understanding of the global regulatory landscape, strong leadership skills, and the ability to ensure the company’s products and services meet all regulatory requirements in each market.Key Responsibilities:Develop, implement, and oversee the regulatory registration strategies for multiple international markets, ensuring compliance with local, regional, and international regulations across LATAM, APAC, EMEA, ASEAN, and other regions.Lead the preparation, submission, and management of regulatory registrations, filings, and submissions for all products/services in the assigned markets. Maintain timelines to ensure timely regulatory approvals and renewals.Ensure the company's products are compliant with all applicable laws, regulations, and guidelines in each region. Monitor regulatory changes, assess the impact, and adjust strategies accordingly.Work closely with internal teams, including product development, legal, marketing, and operations, to ensure alignment on regulatory requirements and business strategies.Maintain strong relationships with regulatory authorities in each market. Stay updated on new regulations, trends, and market conditions, and proactively address potential regulatory challenges. Collaborate with industry associations and represent the company in relevant forums.Oversee the preparation and maintenance of regulatory documents, ensuring accuracy and alignment with regulatory guidelines. Provide regular reports to senior leadership on registration status, challenges, and market updates.Key Qualifications:Education:Bachelor’s degree in Regulatory Affairs, Law, Life Sciences, or related field. A Master’s degree or higher is preferred.Experience:Minimum of 5 years of experience in regulatory affairs or registrations, with at least 2 years in a leadership role.Proven experience managing regulatory registrations across multiple regions, particularly LATAM, APAC, EMEA, and ASEAN.Experience within highly regulated industries (e.g., pharmaceuticals, biotechnology, medical devices, etc.).Skills & Competencies:In-depth knowledge of global regulatory environments and requirements in various regions.Excellent leadership and team management skills.Strong problem-solving abilities and strategic thinking.Exceptional communication and negotiation skills, with the ability to interact effectively with regulatory authorities and internal stakeholders.Proficient in navigating complex regulatory frameworks.Ability to work in a dynamic and multicultural environment.Fluency in English is required; proficiency in additional languages (e.g., Spanish, Mandarin, Portuguese) is a plus.