Our Business and Team:

At Opella Healthcare we aim to become the best FMCH Company IN and FOR the World. We are in a transformation journey to a standalone and more agile organization.

In EM CHC EULA we are focused on the achievement of the Excellence that is under leadership of the diverse team.

The position holder ensures active Quality and Regulatory management of the projects assigned to him/her and ensures appropriate project status reports to project business and EM team members and management.

Important internal and external relations: CHC Quality, Global Quality External Manufacturing, Global Manufacturing & Supply, Sanofi Affiliates, CHC Operations Launch & Transfer Management, Supply Chain Managers, Regulatory Affairs, Quality System Excellence, Supply Chain Excellence

Main responsibilities:

Assurance of Quality and Regulatory management of the projects assigned to him/her and ensures appropriate project status reports to project business and EM team members and management. He/she acts as Projects responsible person for the escalation to resolve Quality & Regulatory issues within scope promptly and to minimize the risk to Sanofi.

Project Management:

• Ensures the assigned projects and related change control activities are consistently and timely managed

• Ensures the transversal management with projects stakeholders

• Ensures identification, assessment, control and communication of risks within scope of responsibility

• Ensure the qualification of new CMOs when required during an Innovation projects

• Ensure the communication and reporting of project status and achievements toward the Project Lead

• Involved in the drafting and negotiation of Quality Agreements with CMOs related to the projects

• Support the standardized ways of working and controls for ongoing projects and knowledge management; identify continuous improvement activities to improve performance.

• Defines the regulatory strategy and participate in change controls meetings

• Evaluates the regulatory dossier and provides input regarding the feasibility of the project from regulatory point of view

• Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs

• Guarantees compliance with GMP and corporate requirements for all regulated activities

• Support and drive performance initiatives in order to adapt all internal processes with FMCH model

• Contribute to the maintenance CMO network strategy of EM Europe

• Transfer the knowledge and the product key information to the regulatory and quality responsible as soon as the project is assigned to the concerned CMO.

About you:

Experience:

• At least 3 years of work experience in Pharmaceutical industry in Quality / Manufacturing / Innovation or Regulatory functions

• Knowledge of project management

• Good understanding of Quality driven environment

• Practical experience in pharmaceutical industry in GMP environment (Quality Assurance and Development or Production / Quality Control). Experience in establishing and maintaining GMP and regulatory compliance.

• Knowledge of national and international current drug regulations

• Practical experience in Regulatory Affairs business.

• Know-how of contractual manufacturing topics is a plus

Soft skills:

• Ability to work in the diverse team

• Performance and result oriented, able to keep agreed timelines

• Strong decision making, problem solving, flexibility skills needed to adapt our organization and processes with FMCH model.

• Communication skills

• Being proactive

Technical skills:

• Commit to customers

• Cooperate transversally

Education:

• Scientific studies in pharmacy, Ph.D. in pharmaceutical sciences preferred

Languages:

• Good English language skills to effectively negotiate and communicate verbally and in writing