Regulatory Affairs

Trasis; Luik; Sur place; EUR 110 000 - 170 000; Plein temps

Avantages offerts par ce poste

Attractive salary

Flexible work environment

Résumé du poste

Trasis is seeking a senior RA CMC Group Manager to define and oversee the Group’s regulatory strategy for APIs, radiopharmaceutical precursors, and related products. You will anticipate regulatory changes, coordinate implementation, and support customers in product adoption.

You will lead a team to harmonize regulatory activities across sites, ensure quality and compliance, and drive market access by defining strategy and managing dossiers with authorities.

Qualifications

• Master’s degree or PhD in Pharmacy or Science.
• At least 5 years of experience in a similar role, including team management.
• Proficient in GMP guidelines.
• Experience in the design and development of Quality Management Systems (methods, procedures).
• Good command of English and French.
• Self-motivated and able to work under tight deadlines.
• Take initiative and are capable of making decisions.
• Excellent written and oral communication skills.
• Proactive and solution-oriented.
• Demonstrates leadership and assertiveness.

Responsabilités

• Translate the company’s strategy and objectives into operational plans and priorities within your department.
• Ensure smooth regulatory activities across the Group by harmonizing practices across sites and monitoring compliance.
• Define, deploy, and steer the Group’s regulatory strategy and policy for efficient market access and manage internal reporting.
• Conduct regulatory monitoring and intelligence covering all Trasis products and uses in strategic regions.
• Disseminate regulatory knowledge within the Group and communicate impacts and opportunities.
• Represent the company in working groups, conferences and events, and develop an external network.
• Oversee regulatory activities for existing products, support clients and internal departments, and manage business risks.
• Lead regulatory support for new products and CDMO projects from evaluation to market launch.
• Oversee preparation, submission, and follow-up of regulatory dossiers for new products with authorities.
• Ensure objectives are met by managing performance and adjusting action plans.
• Identify and manage complex situations, recruit profiles, and develop team talent.

Connaissances

Leadership

Regulatory strategy

Team management

Project planning

Communication

Formation

Master's degree or PhD in Pharmacy or Science

Description du poste

As RA CMC Group Manager, you define and oversee the Group’s regulatory strategy for existing and future products (APIs, radiopharmaceutical precursors, consumables, pharmaceutical intermediates, etc.). Drawing on your strong regulatory expertise, you anticipate regulatory changes, assess their impact, and coordinate their implementation with the Group’s various entities. Together with your team, you oversee the registration and maintenance of regulatory dossiers with the relevant authorities and support customers in the adoption of marketed products.

Responsibilities

• You translate the company’s strategy and objectives into operational plans and priorities within your department, ensuring their integration and alignment across all relevant entities.
• You ensure the smooth running of regulatory activities across the Group by harmonizing practices across sites, taking local specificities into account, and playing a monitoring and alert role to guarantee quality and compliance.
• You define, deploy, and steer the Group’s regulatory strategy and policy to ensure efficient market access for products, oversee all associated regulatory activities, and manage internal reporting.
• You conduct regulatory monitoring and intelligence covering all Trasis products, their uses, and their users, in the Group’s strategic geographic regions.
• You ensure the dissemination and accessibility of regulatory knowledge within the Group, tailoring the level of detail to the needs of the relevant teams, as well as communicating impacts, constraints, and opportunities.
• You represent the company’s interests in working groups, conferences, and other professional events, and develop an external network.
• You will oversee regulatory activities related to existing products to ensure the maintenance of regulatory dossiers, provide support to clients and internal departments, and anticipate and manage associated business risks.
• You will lead regulatory support for new products and CDMO projects, from their evaluation through to market launch, by defining the regulatory strategy and necessary resources in collaboration with internal teams and clients.
• You oversee the preparation, submission, and follow‑up of regulatory dossiers for new products with the relevant authorities, in compliance with applicable requirements and defined deadlines.
• You ensure that objectives are met by managing performance and adjusting action plans.
• You identify, anticipate, and manage complex situations (conflicts, underperformance) by implementing appropriate actions and ensuring regular follow‑up. You define the profiles to be recruited and participate in their recruitment. You develop talent and skills within your team.

Qualifications

• You hold a Master’s degree or PhD in Pharmacy or Science.
• You have at least 5 years of experience in a similar role, including team management.
• You are proficient in GMP guidelines.
• You have experience in the design and development of Quality Management Systems (methods, procedures).
• You have a good command of English and French.
• You are self‑motivated and able to work under tight deadlines.
• You take initiative and are capable of making decisions.
• You have excellent written and oral communication skills.
• You are proactive and solution‑oriented.
• You demonstrate leadership and assertiveness.

Benefits

An attractive and flexible salary according to your experience and performance, with extra‑legal benefits.

A young and friendly work atmosphere, with flexible and dynamic environment.