Product Lead

3 weeks ago


Netherlands, United Kingdom Language Matters Full time

We have a unique opportunity for you to demonstrate your scientific administration expertise within the leading EU institution of medicines and pharmacology based in Amsterdam

You would be a Product Lead (Scientific Specialist) in the Office for Therapies for Immune and Inflammatory diseases, ensuring that high quality, consistent scientific, regulatory and procedural input is provided, throughout the product lifecycle. This isan exciting opportunity to join an institution that provides a truly international working environment where everyone is passionate about public health.

**Your responsibilities will include**:

- Management of a portfolio of products throughout the product life cycle; from initial marketing authorisation (including pre-submission) and through post-authorisation.
- Regulatory and scientific support to scientific committees, the Agency, the EU network of experts, the European Commission, and interactions with stakeholders.
- Contribute to ensure high-quality of EPAR and product information for assigned product portfolio, from clinical/non-clinical perspective.

**Profile**:

- University studies of at least 3 years in the Life Science field (e.g. biology, chemistry, biochemistry, pharmacy).

**Experience**:

- Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in:

- In the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines
- In working with medicinal products containing medical devices and associated regulatory framework;
**Skills & Knowledge**:

- Knowledge of the EU pharmaceutical legislation and regulatory framework;
- Experience in the centralised procedure;
- Experience in liaising with regulatory authorities and public health authorities;
- Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
- Presenting scientific, or regulatory matters at a high level (including experts);
- Experience in dealing with external and internal stakeholders;
- Excellent organisational, communication and time management skills
- Fluency in English and at least one other EU language -Spanish, Czech, Danish, German, Estonian, English, French, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Slovenian, Slovakian, Finnish, Swedish, Greek, Romanian, Bulgarian,Croatian, Norwegian, Icelandic

To apply, please send your CV in English and in Word format to Marie-Anne.
languagematters is acting as an employment agency in relation to this vacancy.


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