Jobbörse

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

Veröffentlicht am 09. Okt. 2026

Im Job Fit analysieren

Wörwag Pharma GmbH & Co. KG

Böblingen

EnglischDeutsch nicht nötig

Zur Originalanzeige

Speichern legt die Bewerbungsmappe an.

Gehalt in der Anzeige

110.000 € bis 150.000 €

Job Fit

Sehen Sie, wie nah Ihr Profil an dieser Anzeige ist.

Über diese Stelle

Introduction

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.

Tasks

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

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!

Competitive, performance-based compensation
Employer contribution to a direct insurance plan
Flexible compensation component
Vouchers for special occasions
Mobility allowance
Subsidized meals in our company canteen
Corporate benefits and employee discounts

Flexible trust-based working hours
Remote working (up to 60%)
30 days of annual leave

Workplace & Environment

On-site parking garage
EV charging stations for cars and bicycles
Excellent public transport connections
Ergonomic workstations
On-site canteen (Vitalbar)
Free water and coffee
Showers and changing rooms

International collaboration
Freedom to develop and contribute your ideas
Hands-on approach & ownership
Strong team spirit
Learning culture

Community & Wellbeing

Regular team events
Health & Wellbeing Days
Work-Life & Wellbeing Platform
Discounts on over-the-counter (OTC) pharmacy products

Responsibility for People & Planet

High-quality products (often as market leaders)
Support for social projects

We are looking forward to receiving your application!

Wörwag Pharma GmbH & Co. KG

Wir zeigen einen Auszug und einen Link je Anzeige, und den vollen Text, wenn die Quelle es erlaubt. Genannte Marken und Logos gehören ihren Inhabern.

Eckdaten der Stelle

Arbeitgeber: Wörwag Pharma GmbH & Co. KG
Position: Head of Global Regulatory Affairs CMC (m/f/x)
Stadt: Böblingen
Arbeitsmodell: nicht angegeben
Sprache: Englisch
Erfahrungsstufe: nicht angegeben
Veröffentlicht: 09. Okt. 2026
Quelle: StepStone

Bewertung des Unternehmens

Glassdoor 3,7
16 Bewertungen
Auf Glassdoor ansehen

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

Job Fit

Über diese Stelle

Tasks

Eckdaten der Stelle

Bewertung des Unternehmens

Ähnliche Stellen

Inside Sales Representative (m-f-d)