Regulatory / Senior Regulatory Affairs Manager CMC, Brussels

Reference: OLI110493R3

Expiry Date: 26-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

Apply for position

Job Description

We have a permanent opportunity for a Senior Regulatory Affairs CMC professional to join a highly successful pharmaceutical company in Brussels.

You will work in an international environment supporting a new MAA planned for 2020 and subsequently move on to supporting post-approval CMC projects.

Our client is a successful pharmaceutical company, R&D driven and with a strong pipeline of new products in development as well as several very successful marketed drugs. This organization excels as a company because of its continual high standards, investing in its people as well as its science, and being able to foster a culture of innovation, collaboration and creativity.

Nature and scope of the role:

  • Support the Regulatory CMC Lead with the preparation and compilation of CMC submission documents for assigned small molecule products
  • Be responsible for regional regulatory expertise and have an input into the development and implementation of global regulatory CMC strategy
  • Responsible for managing the CMC aspects of regional Health Authority interactions.

You will have 4 - 8 years relevant experience in the Regulatory Affairs CMC field and would have successfully authored and contributed to delivering CMC submission documents for development and/or marketed products. Experience of direct communication with Health Authorities on CMC matters is required. 

In return you will:

  • You will work with and be supported by experienced Regulatory CMC leadership where the next step - becoming an Associate Director - will be open to you
  • Flexibility to work from home for 1 or 2 days per week after an induction period
  • Earn a competitive for the industry salary, with a bonus and various company benefits. 

Interested in the above? I look forward to hearing from you!

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.