- Company Name
- Grünenthal Group
- Job Title
- Product Owner Global Regulatory Affairs (m/f/d)
- Job Description
-
**Job Title**
Product Owner Global Regulatory Affairs (m/f/d)
**Role Summary**
Owns and drives the development, delivery, and ongoing optimization of IT solutions that support Global Regulatory Affairs (GRA). Acts as bridge between regulatory, development, IT, and other cross‑functional stakeholders to ensure regulatory processes are fully digitalized, compliant, and efficient.
**Expectations**
- Minimum 8 years of life‑science or scientific technology experience.
- Master’s degree (or equivalent) in science, engineering, computing, bioinformatics, or related field.
- Proven expertise in IT strategy, solution design, project delivery, and service management.
- Strong grasp of regulatory processes (EU/US marketing authorization, renewals, variations, labeling, etc.) and RIM functional processes (registrations, submission planning/content, document management, publishing).
- Fluency in business English; German is an advantage.
- Senior‑level communication, analytical, and leadership skills; customer‑centric mindset.
**Key Responsibilities**
- Co‑create and maintain the GRA IT solution landscape and roadmap.
- Partner with internal and external stakeholders to identify, prioritize, and innovate new IT solutions.
- Ensure all IT products comply with internal security, risk management policies, and external regulatory/statutory requirements.
- Orchestrate stage‑gate/demand processes, guiding the product‑oriented IT team through end‑to‑end ownership of GRA solutions.
- Act as program manager: set up projects, manage execution, and maintain quality and availability of GRA solution services.
- Communicate progress, risks, and outcomes of R&D IT projects to all relevant stakeholders.
- Champion continuous improvement and customer‑centric innovation across the regulatory IT domain.
**Required Skills**
- IT strategy & architecture development
- Product and project management (Agile/Scrum preferred)
- Regulatory affairs knowledge (EU/US)
- RIM process expertise (registration, submission planning/content, document management, publishing)
- Risk management & compliance oversight
- Cross‑functional leadership & stakeholder engagement
- Analytical problem solving and decision making
- Excellent written and verbal communication, presentation at senior level
- Customer‑centric mindset and passion for innovation
**Required Education & Certifications**
- Master’s degree (or equivalent) in science, engineering, computing, bioinformatics, or related discipline.
- Professional certifications in product/project management (e.g., PMP, PRINCE2, CSPO) are a plus.