Head of RA LATAM 100

This role requires a transformative leader to elevate the Regulatory Affairs organization in LATAM, ensuring full regulatory compliance while enabling business growth through new products, customers, geographies, and processes. 

The role provides strategic and technical regulatory expertise, guiding teams to lead with science and pursue a patient-focused strategy that enhances access to treatments. It also develops budgets, policies, and procedures to strengthen the functional infrastructure and oversees critical systems in line with international, regional, and company regulations, standards, and procedures.

Key Responsibilities: 

• Oversee all RA activities in LATAM and ensure that those activities are conducted in compliance with local regulations and company policies and SOPs.
• Support the Business through strong cross-functional collaboration.
• Act as part of the Regional Leadership Team and the strategic management of the business.
• Provides strategic and technical regulatory leadership, expertise, and advice to the organization, including commercial operations, quality, and other groups at the manufacturing and supply organization and the country-based teams.
• Develops budget/procedures to support the functional infrastructure.
• Lead and manage the RA team across the LATAM region.
• Strategically advise the multidisciplinary teams on the regulatory requirements to support the business in a compliant way.
• Assess the company's compliance with local regulations. Develop procedures to ensure regulatory and safety compliance is met and is in line with local and company regulations.
• Develop and implement regulatory operating guidelines/Standard Operating Procedures (SOPs) and common work practices/strategies within the team, including the maintenance of a proper archiving system.
• Ensure adherence to SOPs and that employees are trained accroding to internal regulatory and safety SOPs.
• Lead by ethical principles all RA functions in the region and maintain a positive team spirit.
• Continuously develops staff by making accurate assessments of individuals' capabilities and performance, and providing feedback, coaching, guidance, and mentoring.
• Provide recommendations to decision makers on regulatory, pharmacovigilance, and options on new products or claims that balance business needs with regulatory oversight. Able to manage assigned budgets effectively and maximize investments.
• Interface with Global RA, QA and PV functions to ensure that all activities performed at LATAM are in compliance with the global standards.
• Ensure cross-functional collaboration with commercial and supply chain to ensure the continuity of supply and no business interruption during the submission of regulatory changes in the corresponding country.
• Ensure new opportunities and projects are properly evaluated from a regulatory and safety perspective: due diligence process is in place and due diligence is performed before entering into agreement with any business partner or service provider.
• Support and ensure that inspection from regulatory authorities or audits of commercial partners are well prepared and conducted and support the preparation of corrective and preventive action plans as appropriate.
• Contribute to Health Authorities inspections and follow-up on corrective and preventive actions.
• Ensure good marketing practice of the marketed Arcera products in LATAM.
• Support Scientific activities related to the registered Acino products and participate in Scientific conferences and trainings.
• Contribute to spreading health awareness and pharmaceutical education in the LATAM.
• Follow-up on the importation and exportation of Arcera products.
• Adhere to Arcera internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
• Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

Key Skills and Competencies: 

Key Skills: 

• Leadership capabilities with ability to identify and develop talents for current and future roles.
• Full understanding of legal/compliance environment and requirements.
• Full knowledge and understanding of the different health care systems/sectors in LATAM and international.
• Ability to learn about new technologies, strategies and policies, with high level of compliance with policies.
• Ability to create business relationships with internal and external customers and colleagues in different functions.
• Proven ability to effectively work collaboratively in cross functional teams.
• Strong leadership skills and business acumen.
• Ability to remotely manage people.
• Ability to work in a highly dynamic business environment.
• Excellent oral and written communication and problem-solving skills.

Competencies:

• Strategic ability to manage complex stakeholder relationships and integrate diverse business interests.
• An original thinker with growth mindset with ability to lead effectively regional project teams and organization through complex challenges. An innovator who is able to inspire others.
• Has the ability to serve as thought leader in the understanding and application of evolving basic and translational science, regulatory science, and public health to develop new approaches to improve the development, review and oversight of healthcare products.
• Has the ability to serves as a thought leader in the understanding and application of compliance to develop new approaches to improve compliance performance and culture.
• Capable to identify and evaluate gaps in processes and procedures, assesses risks and elaborates on solutions, mitigation actions. Sets up processes needed.
• Ability to manage assigned budgets and resources effectively and maximize investments.
• Actively engages in talent management and engagement to cultivate a workforce that is well aligned with current and emerging talent needs.
• Continuously develops staff by making accurate assessments of individuals' capabilities and performance, and providing feedback, coaching, guidance and mentoring.
• Demonstrates and proactively advocates working together in a spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.
• Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
• Excellent problem-solving, conflict management skills.

Qualifications & Experience: 

• A university degree in a relevant discipline (Pharmacy, M.D., Biologics, Chemistry), MBA and Ph.D. is advantageous.
• Minimum 15 years of experience within pharmaceutical industry and 3-5 years in a similar position in Regulatory Affairs
• Regional Regulatory experience with development and commercialization of products;
• Experience in leading a successful team, ability to inspire and develop;
• Excellent leadership skills, organizational capability and the ability to foster opportunities for talent development;
• Strong change management skills and experience, to develop and drive an organization focused on excellence
• Proven experience of managing a team across several locations, and of working strategically with the corporate executives to contribute to the overall direction and performance of the company;
• Excellent user of MS Office applications (Word, Excel, PowerPoint, Outlook)
• Experience with electronic systems and databases
• Fluent in English, both in oral and in writing