Pharma Regulatory Affairs Expert

CONSULTYS BENELUX is looking for a Biopharma Regulatory Affairs(RA) Expert to reinforce its Consulting team.

The main accountabilities of a RA Expert is to plan and execute the necessary regulatory activities to progress a Project portfolio with the ultimate aim of obtaining marketing authorizations globally.

Major Accountabilities and Responsibilities

• Contact person for assigned responsibilities on the product

• Assume responsibilities for contact with 3rd party partners (mainly CROs), building strong relationships for assigned project(s)

• Responsible for providing regulatory expertise and strategy

• Handle major variations with the project team: eCTD content, modules review/input, responsible for Module 1, submission planning, label update.

• Support and deliver quality regulatory submissions in compliance with the applicable regulations, directives and guidelines, and following the agreed strategies and timelines.

• Ensure that all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc).

• Prepare and communicate regulatory strategic and operational plans for assigned projects

• Maintain awareness of external regulatory environment, new guidelines and legislation

START DATE: ASAP

WORK LOCATION: Wallonia, Belgium

ABOUT YOU:

You have at least 5 to 10 years of experience in Biopharma Regulatory Affairs.

With:

• Experience in EU regional regulatory procedures and legislation related to drug development and clinical trial applications.

• Strategic and results-focused - ability to overcome obstacles and achieve key outcomes

• Strong project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.

• Product development experience: agency interactions (pre-submission meeting, scientific advice ... etc), orphan designation, CTAs, study protocol/IBs/CSR input and review, PIPs

• Life cycle management experience

• Analytical - Integrity - Flexibility - Adaptability - Leadership - Responsible are key soft skills

• Facilitates and coordinates teams and processes with appropriate use of interpersonal skills

• Build effective partnerships - identifies opportunities and takes actions to build effective relationships within the team and with other areas

• Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate

• Sensitivity to the diverse cultures comprising- the international and global environment

ABOUT US:

• For nearly 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.

• We cultivate a human-scale company spirit that allows us to personally follow our 450 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium and Switzerland, Germany, we offer everyone geographical stability, without a mobility clause in the contracts. 

• Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.