Head of Regulatory 100% (m/f/d)

• 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

• 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.

• 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.

• 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.

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

• 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.

• 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.

• 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.

• 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

Acino