(Sr.) Lead Regulatory Affairs

il y a 5 heures

Gosselies, Belgique Catalent Temps plein

**Position Summary**

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to lead optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for **(Senior) Regulatory Affairs Lead**

**The Role**

A regulatory affairs senior lead primary duty is to support regulatory for product development and manufacturing activities to ensure compliance with regulations and to support preparation and filing of regulatory submissions for clients. Responsibilities include:

- Interpret and evaluate reports and other documents to be used in all typical regulatory submissions,
- Review study protocols and guidance pertaining to Regulatory Affairs and regulatory compliance,
- Prepare for and leading regulatory meetings,
- Design regulatory compliance strategy to ensure compliance with regulations,
- Asist in training of regulatory department and cross-functional areas in regulatory requirements,
- Review change control for potential impact on client or company submissions,
- Provide regulatory guidance and support for development and production activities,
- Interact with clients and maintaining awareness of changes in regulatory requirements for effective regulatory submissions.
- Provide expert advice at all phases of development
- Coordinate, lead, author and/or review regulatory assessment, Health Authority meeting documents, investigational and commercial submissions and other regulatory documents
- Support inspections from local and foreign authorities
- Demonstrate Leadership Capability
- Manage direct reports
- Provide tactical & limited strategic direction up to 3-6+ months in advance
- Provide coaching and mentoring to others on the team and cross-functionally
- Master’s degree preferred, scientific orientation
- Well acquainted with Change Control and compliance management system
- Good knowledge of quality tool
- Minimum 8 years GMP experience, preferably in cell and/or gene therapy
- QA experience
- Experience in customer relationship is an asset
- Familiar with regulatory guidance
- Fluent in English, good command of French, German language is an asset (support of site in Dusseldorf)
- Computer literate, Microsoft Office
- Rigorous, conscientious, analytical, reflexive
- Quality mindset
- Ownership
- Willing to bring new challenges
- Excellent communication skills
- Demonstrated Leadership Capability

**Position Benefits**
- Full-time position (40h/week).
- An indeterminate contract.
- Group & health insurance
- Meal vouchers & Eco Vouchers
- Company car
- The opportunity to take part in a growing dynamic biotech company.
- A human-sized working environment with a convivial atmosphere.

**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**:

- Delivers Results
- Leads with Integrity and Respect
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops

**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.

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