Pharmaceutical Scientist, Chemist - Regulatory Affairs (m/f/d)

Beschreibung

GRA Pharmaceuticals is responsible for licensing of new pharmaceutical veterinary medicinal products (VMPs) and for the regulatory maintenance of licensed pharmaceutical VMPs world-wide except US. The implementation of the new veterinary legislation, Regulation (EU) 2019/6, requires a variety of additional regulatory tasks. The Specialist supports the necessary administrative regulatory procedures and data management to ensure compliance with the requirements of the new veterinary legislation.

We are looking for a

to join our team in Schwabenheim to support support licensing activities for our Animal Health pharmaceutical product portfolio. The position is full time and limited to 4 years.

• Arrange documents, data, and all other items necessary maintaining marketing authorizations. Ensure timely availability of the requested materials, in line with the licensing strategy.
• Enter and manage data in the GRA data bases, support corresponding functions in data management.
• Update GRA data bases continuously.
• Maintain a clear and standardized filing / archiving system for documents and correspondence, support corresponding functions in document management.
• Format, structure and send out submission packages to the local country organization and/or competent authorities and ensure timely follow up.
• Follow the development and emergence of new regulatory requirements & trends for pharmaceuticals
• Ensure compliance with internal and external regulatory standards.

• Bachelor’s degree or equivalent, preferably in applied science. If no higher professional education, then proven skills and experience to work at such level
• Experience in a compliance / regulatory affairs environment within the human or animal health industry.
• Experienced in the work with information systems and databases.
• Experienced in working with international contacts, able to be patient and open to other cultural habits.
• Excellent communication skills.
• Proficient in English.
• Proficient in MS Office applications
• A service minded team player; accurate and well-structured way of working.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for man

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.