Regulatory Affairs Liaison MFD

Job Description

Do you want to be part of our Regulatory Affairs Europe team supporting accessibility to our new and already registered medicines

We have a new exciting opportunity for a Regulatory Affairs Liaisonto 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 the supervision of the (Senior) Principal Scientist of Regulatory Affairs. You will be responsible for implementing strategies for products in development with their guidance and independently developing and executing strategies for registered products. Additionally you will play a crucial role in managing submissions and interactions with the EU regulatory agencies. It will be your responsibility to directly liaise with HQ US-based cross-functional teams effectively communicating regional requirements and ensuring compliance with all necessary regulations for assigned projects. You will also coordinate or oversee the preparation of regulatory documentation in a timely manner aligning with corporate objectives. Furthermore as an integral part of the team you will serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.

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. 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

• Under supervision from the (Senior) Principal Scientist 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 with cross-functional project teams to develop and implement regulatory strategies including scientific advice pediatric investigational plans and orphan designation.

• Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.

• Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission assessment and quick approval of CTAs under the EU Clinical Trial Regulation.

• Serve as the primary regulatory representative to regulatory agencies and Country RA teams.

• Act as the Regulatory Affairs representative on assigned non-product related cross-functional teams.

• Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.

• Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.

Your profile

• Masters degree in pharmacy chemistry or equivalent preferably in a science-related field. Minimum of 2 years of experience in the pharmaceutical industry is preferred.

• Strong organizational and planning skills with the ability to manage multiple projects and adapt to changing priorities.

• Knowledge of EU regulations guidelines and regulatory processes for product life cycle maintenance.

• Ability to work in a cross-functional and international environment.

• Fluent written and spoken English is required along with strong interpersonal oral and written communication skills.

• Digital & AI literacy (use of AI-enabled tools to support regulatory administrative and process-improvement activities).

• Willingness to travel up to 5% for job-related activities.

Required Skills:

Preferred Skills:

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