RA Senior Associate Oncology

RA Senior Associate Oncology - Leiden, Netherlands

Duties:

- Supporting all regulatory activities associated with the development, post-approval and life cycle management for designated products within the Oncology portfolio
- Providing regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate.
- Providing guidance and support to product development teams on regulatory issues.
- Excellent relationship building skills with the ability to communicate at all levels
- Knowledge of how Health Authorities operates and a good general knowledge of HA organizational structure and individual responsibilities in those structures

Requirements

- European and/or Global regulatory experience
- Proven Full product life cycle experience
- Proven regulatory strategy experience
- Experience within a clinical trial programme environment and CTA procedures.
- Proven expertise of Pharmaceutical Regulatory Affairs on an international basis.
- Business development skill sets with exposure to or having worked in a regulatory consultancy model.
- Proven ability of interpreting legislation and impact to meet commercial needs.
- Proven capability of successful working relationships with regulatory bodies.
- Excellent communication and interpersonal skills, ability to influence.
- Creative and innovative, embraces the new.
- Demonstrate consequential thinking.
- Excellent attention to detail.
- Degree or equivalent in a Life Science.
- Excellent communicator, both verbal and written in English and Dutch.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.