Contact

CONSULTANT CMC REGULATORY AFFAIRS
12-12-2018

#CONSULTANT CMC REGULATORY AFFAIRS

As a result of the continuous growth of our company including our Regulatory Affairs Division we are looking for experienced professionals in Regulatory Affairs CMC. We offer a challenging environment working within our teams and for a wide range of clients in a role as (senior) consultant RA-CMC.

Being a consultant you will work on a wide range of projects that may cover the complete life cycle of a product from (early) development up to post approval maintenance. The projects range from small molecules to biologicals depending on your knowledge and experience. You can be assigned to customers looking for hands-on support and/or requiring advice on regulatory-CMC. The work may cover all aspects of RA-CMC ranging from development and advise on RA-CMC strategies, implementation of RA-CMC requirements in product development, support in scientific advice procedures, communication with health authorities and RA-CMC (Module 3, IMPD) technical writing. You may work at different sites which may be the office of our client, Xendo office or home based depending on the project requirements. Communication skills are key as you will communicate with many different functions within our client organisations like: RA, QA and QC functions, development, manufacturing but also with health authorities.

YOUR PROFILE

We are looking for highly motivated professionals who like to act in a dynamic environment and are able to adjust to different working environments. You are a self-starter and quick learner with excellent communication skills. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. Experience in CMC Regulatory Affairs within the (bio)pharmaceutical industry or health agencies is preferred. For the role of senior consultant several years in a (senior) CMC related position are required. Depending on your experience it is not an absolute requirement that the candidate will be based in the Netherlands. Fluency in English is required.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are also well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of regulatory changes on the products or portfolio of your customers.

OUR OFFER

We offer a responsible, independent position in a growing and ambitious organization, with the opportunity to develop yourself. We offer a competitive salary and secondary benefits. Xendo has a professional but informal working environment, an extended development program on hard and soft skills, a flexible and pleasant work atmosphere and over 200 international colleagues.

APPLYING

If you are interested in this position, we encourage you to send your motivation and CV to us with the form below.

Agency or sales calls are not appreciated


React on this open vacancy

Attach your resume
Size limit for each file is 20.0 MB