Regulatory affairs director Jobs in Dettenhausen

Wörwag Pharma –   a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Böblingen near Stuttgart, Germany, which recognized and scientifically proved the importance of biofactors very early on. For more than 50 years, we have been fighting the civilization diseases of our time - preventive, accompanying, healing. Our slogan "Getting closer helping better" is not just a promise to doctors, pharmacists and patients. It is an expression of our colorful corporate culture and our collegial cooperation among our now 1,200 employees worldwide.

Become a part of our team in our headquarter in Böblingen (near Stuttgart) because we are looking for you as a

Specialist Medical Writing and Advice (m / w / d)

These tasks await you

Collaboration for preparation of parts of eCTD dossiers which are relevant for marketing authorisations in accordance with regulatory and internal specifications for European and global marketing authorisation

Review and evaluation of the accuracy, consistency, and plausibility of externally produced clinical and non-clinical documents which are relevant for marketing authorisation

Review and evaluation of information texts for medicinal products and food supplements

Interface / support of Regulatory Affairs and Global Pharmacovigilance in medical / scientific issues

Editing / review of technical information and directions for use with regard to medico- scientifically relevant passages, e.g., Originator adjustments, reviewing the SmPC and PIL for Deficiency Letter answers in German for Biofactors portofolio

Collaborating with the manager of the Generic portofolio, to complete Originator Adaptation process and maintain the Generics PILs and SmPCs up-to-date and compliant

Contact person for regulatory authorities and internal customers relating to non-clinical and clinical questions on dossier parts

Ensuring compliance with internal deadlines and quality specifications for the above-mentioned processes

What you bring with you

Successfully completed scientific studies or a comparable scientific education (e.g. Master, Pharmaceutical sciences, Medical sciences, Engineering level)

Several years of professional experience in the fields of Medical Affairs (Medical Writing) and / or Regulatory Affairs / Regulatory Medical Writing is a plus

Pronounced ability to produce written documents of high quality and check the technical content of externally produced documents

You are used to working in a team, but also independently, accurately and in a goal-oriented manner.

Analytical and structured way of thinking and working

Very good communication and assertiveness skills, German as a native language or the equivalent of a C1 level as well as a very good command of English

We offer you

• A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
• Varied challenges, as well as exciting projects with a strong team spirit
• Compensation in line with the market and your performance, as well as additional benefits which can be used flexibly according to your needs, e.g.,

Subsidy for direct insurance