Job Description

We are looking for a Content Editor to join our CMC Regulatory Market Access team. This is an amazing opportunity to work on product. The team consists of 43 colleagues and is reporting to Senior Team Manager.

About You – Experience, Education, Skills, And Accomplishments

• Graduate or Postgraduate in Life Sciences
• At least 1 years’ experience in pharmaceutical development, CMC manufacturing or CMC regulatory affairs.
• Strong knowledge of quality aspects of drug development and ICH requirements.
• Experience on submissions, post-approval changes, responses to deficiency letters and communications with health authorities on quality aspects of the product is required.

It would be great if you also had . . .

• Knowledge of Biological entities would be appreciated.
• Knowledge of another European language.

What will you be doing in this role?

Maintenance of the CMC regulatory database

• Monitor the evolution of CMC regulatory landscape worldwide.
• Analyze the changes in the CMC requirements and implement them in the database. The content editor must act as internal expert for a set of countries.
• Work in collaboration with a pool of external consultants.

Administrative tasks

• Undertake the research and identification of local CMC experts, negotiation of contract terms and copyrights when needed.

Customers/internal support

• Provide support and act as team representative for customers when required.
• Communicate relevant information to concerned stakeholders.

About The Team
Regulatory Intelligence information is part of the Life Science and comprises several teams responsible for the daily collection, synthesis and maintenance of data relating to regulatory information. These records form a core element of Product