Senior Regulatory Affairs Associate – Drug/Device – Respiratory Innovation Centre (contract)

Description of Services

invoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Our vision is to be a leading global biopharmaceutical company with an advancing pipeline of products addressing the unmet healthcare needs of patients.

To help continue our growth and success, we are looking a UK based Contract Senior Regulatory Affairs Associate to support the delivery of strategies for obtaining and maintaining Marketing Authorizations for invoX Belgium Respiratory Innovation Centre’s portfolio of Soft Mist Inhalation products.

The contractor will work within a complex matrix environment with multiple stakeholders and on cross-functional teams to advise on drug development process, dossier requirements and global regulatory procedures. The contractor will lead projects, inputting into engagement with Regulatory Agencies and Notified Bodies to agree supporting data packages. With the assistance of external regulatory teams, the contractor will support the generation of dossiers and technical files that are compliant with regulatory requirements and ensure that risks are identified. After approval the contractor will maintain the Marketing Authorizations and Technical Files to ensure ongoing compliance.

Services required

Working closely with invoX Belgium Respiratory Innovation Centre Head of Regulatory, R&D Scientists and Device Engineers, the tasks can be described as follows:

• Take responsibility for supporting regulatory activities for several inhaled drug development projects, becoming the key regulatory contact internally and with external partners.
• Support the implementation of regulatory strategy for projects, including the creation of global regulatory MAA dossiers, IMP dossiers, medical device technical files. Advises on content of dossiers and regulatory process.
• Work with senior regulatory team to provide informed regulatory opinion to cross functional team based on experience and expertise.
• Support scientific advice/agency meeting activities, briefing book generation and attends meetings.
• Takes responsibility for several key topics in regulatory intelligence and monitors environment for updates. Works with senior regulatory team to understand impact of changes.
• Works within electronic systems for management of documents and processes.
• Adhere to federal, state, and local health, safety and environmental regulations.
• Execute duties in accordance with invoX Belgium RIC SOPs.

Experience needed to fulfil services

• A Bachelor or higher degree in pharmaceutical, biomedical or chemical science or equivalent experience.
• Relevant experience, ideally in pharmaceutical or medical device regulatory affairs.
• An understanding of the drug development process, dossier requirements and regulatory procedures for gaining approval and maintaining Marketing Authorizations or Medical Device Certification.
• Experience of drug device combination products.
• Experience or interest in respiratory diseases.
• Strong project and people management skills.
• Experience of working effectively in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
• Strong communication skills and are an excellent negotiator. You have experience in written and oral communications with Regulatory Agencies or Notified Bodies.
• Fluent in English, both written and spoken.
• Experience in an international environment and ability to travel regularly to the office in Diepenbeek, Belgium and abroad to support engagement with Regulatory Agencies or with external parties.