Regulatory Affairs Liaison Oncology
il y a 2 semaines
Do you want to be part of our Oncology division, helping people fight cancer, supporting accessibility to our cancer medicines, and pursuing research in immuno-oncology to bring new hope to people with cancer?
We have a new, exciting opportunity for a **Regulatory Affairs Liaison Oncology (Associate Principal Scientist) **to be based in Oss (NL), Brussels (BE), or London (UK).
**Purpose of the position**
In this role, you will have the opportunity to coordinate regulatory activities in the EU, UK, Switzerland, and non-EU SEE countries under mínimal supervision from the (Senior) Principal Scientist of Regulatory Affairs. Your responsibilities will include developing and implementing strategies for products in development with mínimal supervision, as well as independently developing and executing strategies for registered products. You will be responsible for managing submissions and interactions with the EU regulatory agencies, ensuring smooth processes, and troubleshooting and resolving any critical issues on the path to product registration.
Additionally, you will provide regulatory support, guidance, and expertise to HQ US-based internal groups, ensuring that all applicable regulatory requirements are considered and properly incorporated into development programs. Your role will also involve coordinating or overseeing the preparation of regulatory documentation to meet corporate objectives in a timely manner. Furthermore, you will serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams, actively contributing to the success of the organization.
**The department**
Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. Our group covers a wide range of activities related to getting products on the market and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Cancer is one of the most significant global health challenges today, representing one of the world’s most urgent unmet medical needs. Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. Our current portfolio in oncology is creating countless opportunities and challenges for the oncology team. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day
**Primary activities**
- With mínimal guidance from the (Senior) Principal Scientist, Regulatory Affairs Europe, coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
- Work closely with cross-functional teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation, while identifying regulatory risks and facilitating the earliest possible approval of new compounds, with mínimal supervision from the (Senior) Principal Scientist. Ensure alignment of regulatory strategies with project teams and business objectives.
- Take accountability for interactions with regulatory agencies to ensure smooth submission, assessment, and quick approval of CTAs under the new EU Clinical Trial Regulation, liaising with regional Country RA teams and other internal stakeholders.
- Serve as the primary regulatory contact with regulatory agencies and Country RA teams.
- Represent Regulatory Affairs on assigned non-product related cross-functional teams, actively contributing to the development and implementation of effective processes that align with business objectives and ensure compliance with regulatory requirements.
- Attend relevant external meetings and courses to stay up-to-date with advancements in product area, international regulatory activities, and the pharmaceutical industry as a whole.
**Your profile**
- M.D., Ph.D. or master’s degree with at least 3-4 years of experience in clinical research or regulatory affairs is required. Individuals who have demonstrated competence in biomedical research gained through appropriate experience of 1-2 years and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered.
- Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment; able to manage complex projects by exercising independent decision making and analytical thinking skills.
- Knowledge/experience of EU regulations, guidelines and regulatory processes for NCEs and product life cycle maintenance; ability to work in cross-functional and international environment.
- Detail
- and goal-oriented, quality
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