Senior Global Regulatory Cmc Scientist - Brussels, België - Keyrus Life Science Belgium

Keyrus Life Science Belgium

Geverifieerd bedrijf

Brussels, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

What we offer
Joining our consulting team in Belgium means 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.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth.

On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization ) based on your background and experience.

Keyrus Life Science is looking for a
Senior Global Regulatory CMC Scientist to join our consulting team for a client project based in
Brussels.

An opportunity to:

Take responsibility for the regulatory
CMC support of Small Molecule products throughout the
Life-Cycle.

-
Define strategy, planning and preparation of regional specific Quality submission documentation for assigned geographical regions and contribute to the preparation of global submission documentation to deliver timely approvals to meet business needs.

Leading and/or
provide regulatory CMC input to all Health Authorities (HA) interactions on CMC matters in assigned regions as delegated by Global Regulatory CMC Lead and agreed with the GRA Leadership Team and the operating units.

You will be responsible for:
-
Developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to
deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.

Taking "Handson" accountability by managing CMC projects yourself and
writing regional and global Quality documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines.
Ensuring effective
communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Teams, Supply & Technology Solutions (S&TS) Teams, Development and Commercial Teams as agreed with the Global Regulatory CMC Lead.
Identifying supporting
Quality documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
Regulatory
assessments for CMC changes** and creation of entries and updates in the designated systems (Trackwise, Veeva Vault, etc.) within defined timelines.
Leading or providing
input to internal regulatory business initiatives and cross functional work streams as assigned.

Profile*- Bachelor's Degree, Master's preferred in a relevant life science or business-related discipline.

At least
5 years of relevant Regulatory Affairs CMC experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity.
Preferably some professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities.
Fluency in
English; French is a plus.

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 skilfully, 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.