Founded in 1968, Randstad Germany is the experienced and competent personnel service provider. We guarantee attractive remuneration and a secure, permanent job at Germany's number 1 personnel service provider. You are looking for a new challenge? Then we have the right job for you: For our customer, a pharmaceutical company in Frankfurt am Main, we are currently looking for a Regulatory Expert.

Das dürfen Sie erwarten

Performance-related pay in accordance with the BAP/DGB collective agreement
As a rule, an employment contract of indefinite duration
Up to 30 days holiday per year
Representation by a nationwide general works council
Preventive health care through our company medical centre - free services in all aspects of occupational medicine and individual answers to your health questions

Ihre Aufgaben

Supports batch release by following submission and approval to ensure the product regulatory compliance
Ensures that the CMC dossier is in line with manufacturing and control procedures and with dossiers approved by Health Authorities
Contributes to site inspections and audits
Supports product licenses maintenance and site registration
Reviews and signs-off documents like SOPs or technical reports
Assesses and manages change control activities with regulatory impact for the site
Provides regulatory expertise to site projects
Manages regulatory activities linked to change controls including updating of the CMC files
Supports Marketing authorisations worldwide (territory extensions, renewals, site registrations and transfers, new submissions)
Optimizes the content of CMC dossiers to facilitate the management of future changes
Writes ready for submission CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions and supports CMC writing performed
Prepares with contribution of site experts answers to questions from Health Authorities

Unsere Anforderungen

Ph.D or Master in a science/health field (e.g. Mathematic, Chemistry, Pharmacy, Biology, Biotechnology Sciences etc.) or equivalent
Knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends is perferrable
Several years of direct Regulatory CMC experience is preferred
Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
Experience of manufacturing operations, Biotechnologies, Biological products is a plus
Capability of resolving strategic technical and regulatory issues
Should demonstrate initiative, independent thinking and anticipatory foresight
Strong communication skills
Business level in German and English (written & spoken)

We offer you a family friendly permanent employment with good social benefits and attractive payment. Apply today and be happy in your new job tomorrow! Interested?

For more than 50 years, Randstad in Germany has been a serious and competent partner for both, young professionals and experienced specialists. We offer more than 50,000 employees a secure job, attractive remuneration and entry to interesting customer companies. In more than 550 branches in Germany we are driving customers and candidates to success.

At Randstad, we all stand for the promise of moving forward together. We always strive to improve and be innovative. We want to inspire our customers, employees and applicants with everything we do - down to the smallest detail!

Corona virus and application at Randstad: Our application process supports our "Human Forward" promise. This currently means: Avoid personal contacts, because the health of our candidates and employees and our shared social responsibility have top priority for us. Therefore, our application process is still completely possible without direct and personal contact.

Apply now online as a Regulatory Expert to join a successful team! Applications from severely disabled people are very welcome.