Head of Global Regulatory Affairs CMC (m/f/x) in Böblingen

From a local pharmacy to an international pharmaceutical company: that's us, Wörwag Pharma.
Our mission: Together for a healty life. We help to prevent and treat diseases of our time. Every day, we are committed to giving everyone the chance to live a healthy life – and have been doing so for more than 50 years!
Would you like to actively support us with this plan? Then apply now, because we are looking for you to start as soon as possible as a

Head of Global Regulatory Affairs CMC (m/f/x)

The Head of Global Regulatory Affairs – CMC holds a key position within our global organization and is responsible for defining and implementing the company-wide CMC strategy in the areas of development, regulatory approval, and lifecycle management. The position combines strategic and organizational leadership responsibilities with hands-on involvement in regulatory CMC matters—particularly those that are complex, high-priority, or business-critical—as appropriate. The position holder reports to senior management, leads a global team across various locations, and serves as the primary Regulatory CMC point of contact for Quality, Product Development, Supply Chain, Manufacturing, and Sales, as well as for the entire Global Regulatory Affairs division.

Responsibilities

• Technical and disciplinary leadership of the global Regulatory Affairs CMC function, including the HQ team and resources at other locations
• Responsibility for all global CMC activities, including both new submissions and lifecycle management of existing approvals, as well as strategy development
• Operational support for complex and business-critical CMC projects, including dossier preparation, reviews, and communication with regulatory authorities.
• Establishment and management of governance structures for regulatory risks, escalations, prioritization, and decision-making
• Ensuring regulatory compliance of all CMC dossier content (particularly Modules 2.3 and 3) worldwide
• Assessing the regulatory implications of product, process, and manufacturing changes, and coordinating implementation strategies with relevant functions
• Leading regulatory activities related to site relocations, technology transfers, network changes, and post-approval strategies
• Responsibility for due diligence activities in the context of business development, in-licensing, and M&A with a focus on CMC
• Leading resource, budget, and capacity planning, including prioritization, forecasting, and efficiency improvements
• Developing employees, ensuring readiness for audits and inspections, and advising executive management on regulatory CMC issues

Requirements

• A college degree in pharmacy, chemistry, pharmaceutical sciences, life sciences, or a comparable field
• At least 10 to 12 years of professional experience in regulatory affairs and/or product development with a strong focus on CMC
• Several years of leadership experience managing large, international teams, some of whom work remotely
• In-depth knowledge of international regulatory requirements and guidelines (e.g., ICH, GMP, WHO) with a focus on CMC
• Demonstrable practical experience in CMC dossier preparation, evaluation, and lifecycle management
• Ability to combine strategic leadership responsibilities with hands-on involvement in complex technical issues
• Strong knowledge of process and project management, digitalization, automation, and AI applications in the regulatory environment
• Entrepreneurial mindset and the ability to balance compliance, business requirements, and feasibility
• Strong persuasive skills at the senior management and regulatory agency levels, as well as experience in cross-functional change and improvement projects
• Excellent English skills, intercultural competence, high integrity, and willingness to travel occasionally

We are looking forward to receiving your application!