Are you an experienced "Regulatory Affairs CMC" professional, fluent in Dutch and English, with a degree in science and looking for a new opportunity ? Then this mission at our client in Puurs may be what you are looking for !
Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
- Prepare CMC responses to health authority questions during development, registration and product lifecycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Establish and maintain sound working relationships with partners and customers.
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
- Bachelor or Master degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Fluent English and Dutch required (oral and written).
- Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable.
- Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
- Effective planning, organizational and interpersonal skills.
- Reasonable approach to risk assessment.
- Excellent written/spoken communication and negotiation skills.
- Computer literacy.
- Full-time Position
- A balanced salary package based on your capabilities and experience
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 18010