Regulatory Affairs consultant (CMC)

What we offer

Joining our consulting team in Belgiummeans giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

Job Description

As a Regulatory Affairs Consultant you are the key person in the submission of technical (quality) changes. You take part in the operational activities for the CMC submissions related the life cycle maintenance of Vaccines (CMC variations, commitments, market expansions, answers to questions from world-wide regulatory authorities). In overall, you maintain regulatory dossiers and interact of course a lot with other regulatory teams (QC, QA, Production, Supply) to ensure File content definition. You are at ease with the use of regulatory information management systems.

Day-to-day activities

• execution of European Regulatory CMC strategies,
• submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD’s, MAA’s…) to regulatory agencies.
• potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides.
• preparation of CMC information for submission to EU regulatory agencies,
• generate CMC strategies,
• assess risks and develop contingency plans,
• ensure that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements
• support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff… in order to discuss and define regulatory applications (Quality Module, Responses, Commitments.
  

Profile

Scientific degree in a relevant subject (Chemical, biochemical). Ideally min. 2 years relevant operational experience.
Experience in international regulatory affairs for vaccines dossiers is required.

Working as a Consultant you demonstrate:

• Excellent cross-cultural awareness and understanding
• Fluency in the English Language is essential
• Excellent communication, interpersonal and relationship building skills

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.