Job Description

This role requires a transformative leader to elevate the Regulatory Affairs organization, ensuring full regulatory compliance while enabling business growth through new products, customers, geographies, and processes. As a key member of the Regulatory, Pharmacovigilance, and Medical leadership team, the position collaborates with senior management, regulatory authorities, and TechOps functions--such as Quality, Medical, and Pharmacovigilance--to safeguard compliance and patient safety.
The role provides strategic and technical regulatory leadership, guiding teams to lead with science and pursue a patient-focused strategy that enhances access to treatments. It also develops budgets, policies, and processes to strengthen the functional infrastructure and oversees critical systems in line with international, regional, and company regulations, standards, and procedures.
Key Responsibilities:
Leadership & Strategy:

• Provides strategic and technical regulatory leadership, expertise and advice to the organization.
• Provides recommendations to decision makers on regulatory matters.
• Anticipates regulatory and public relations issues and develop strategies and action plans to protect the integrity of the company.
• Anticipates, evaluates and influences (both internally and externally) global regulatory trends and legislation.
• Builds COREx (Centre of excellence activities) - harmonization, continuous improvement activities, increased capabilities, and efficiencies.
• Support Scientific activities related to the registered Acino products and participate in Scientific conferences and trainings

Operational management:

• Directs and oversees all operational regulatory activities.
• Creates and implement crisis management plans and procedures.
• Approves regulatory strategies.
• Advises on regulatory topics for in house development and in-licensing projects.
• Ensures new opportunities and projects are properly evaluated from a regulatory (for example through Due Diligences).
• Ensures all received Product Quality Complaints, Adverse Events and Medical
• Information Requests by the organisation are directed to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

Manages Regulatory requirements and external stakeholders:

• Ensures adherence to standard operating procedures, good practices (GxP) and other applicable legislation
• Ensures inspection from regulatory authorities or audits of commercial partners are well prepared and conducted, and support the preparation of corrective action plans (CAPAs) as appropriate
• Anticipates, evaluates and influences global regulatory trends and legislation.
• Ensures up to date internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at regulatory and other training.

Key Skills and Competencies:
Knowledge and skills:
Scientific expertise:

• Ability to represent the company on regulatory issues internally and externally.
• 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.
• Strong understanding of drug development, manufacturing process, quality control and quality assurance, bioequivalence topics, and various international regulatory requirements and registration procedures.

Teamwork/collaboration:

• Excellent communication and interpersonal skills, demonstrated ability to work collaboratively with cross functional teams, ability to interact positively with all functions.

Leadership:

• Strong influencing skills, making timely decisions using relevant data, ability to deal with different audience levels;
• Ability to challenge the status quo and foster change;

• 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 globally.
• Ability to learn about new technologies, strategies and policies, with high level of compliance with policies.

Operational management:

• Experience and competence in managing complex organization across multiple geographies and cultures.
• Strategic ability to manage complex stakeholder relationships and integrate diverse business interests.
• 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.

Competencies:

• 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, e.g. Pharmacy, M.D., Science, etc.
• Minimum 15 years of experience within pharmaceutical industry and 3-5 years in a similar position in Regulatory Affairs
• 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

Skills Required