Description
The invoX Respiratory Innovation Centreis dedicated to the development of innovative and generic drug-device combination products which use the Softhaler®, a next-generation soft-mist device, to deliver known active pharmaceutical ingredients (APIs), new chemical entities (NCEs) and biomolecules to the lung.
To help continue our growth and success, we are lookingaSenior Associate Regulatory Affairsto support the delivery of strategies for obtaining and maintaining Marketing Authorizations for invoX Belgium’s RIC portfolio of Soft Mist Inhalation products.
You 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. You will lead projects, inputting into engagement with Regulatory Agencies and Notified Bodies to agree supporting data packages. With the assistance of external regulatory teams, you will support the generation of dossiers and technical files that are compliant with regulatory requirements and ensure that risks are identified. After approval you will maintain the Marketing Authorizations and Technical Files to ensure ongoing compliance.
Key Responsibilities
Working closely with invoX Belgium RIC 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.
Skills, Knowledge and Expertise
- 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 would be advantageous.
- 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.
Why work at invoX?
We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a Hong Kong listed, global top 40 pharmaceutical company with more than 24,000 employees. UK-based invoX is an expanding biopharmaceutical company focusing on R&D, Clinical Development and Business Development activities in the UK, EU and US, with a core focus on oncology and respiratory therapeutics.
Our core team is made up of a multicultural international group of highly experienced individuals with life sciences and technology-centred backgrounds, all with a mutual passion and ambition for creating something different.
Mission: invoX’s mission by 2026 is to be a globally recognised, fully integrated pharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs.
Purpose：We aspire to improve people’s lives by creating access to innovative medicine.
Vision: To be a leading global pharmaceutical company through delivering innovative therapies for patients.
