Regulatory CMC Specialist

  • Aerotek
  • Dec 02, 2021
Full time

Job Description

This is an exciting opportunity to join a global leading Clinical Research organisation within their dynamic CMC team. The role will require you to provide CMC subject matter expertise to a leading pharmaceutical client giving you excellent career development opportunities including progression opportunities within the company.

*In this role you will be required to:*

* Acts as a Regulatory Team Leader on complex projects, which may include technical writing.

* Prepares and review regulatory documentation in area of expertise, as appropriate.

* Establishes relationships with many customers as well as working with cross functional teams and stakeholders

* Acts as a subject matter expert for Regulatory Chemistry, Manufacturing and Controls

*We are looking to speak to candidates with:*

* At least 3 years Regulatory CMC experience including post marketing submissions

* Experience reviewing and approving change request controls

* Experience taking ownership for assigned products

* A life science degree (Masters preferred)

* Experience working cross functionally and managing multiple stakeholders

This is an excellent opportunity to join a global leading company who make a positive impact on millions of people around the world.

This is a permanent role which will give you the chance to become a valued member of the team and eventually progress into a leadership position.

This role can be fully remote based from anywhere in Europe and is offering a competitive salary as well as an attractive benefits package.

We are looking for people to join immediately so apply today!

"Regulatory" "Regulatory Affairs" "CMC" "Regulatory CMC" "Regulatory