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Senior Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will play a crucial role in supporting our clients in the chemical industry with regulatory affairs and product stewardship.
Key Responsibilities:
- Provide subject matter expertise in chemical legislation and regulatory affairs to support our clients in the chemical industry.
- Develop and implement authorisation strategies and provide regulatory advice to clients, including the development of testing programmes for industrial chemicals.
- Compile approval/authorisation dossiers according to EU and GB Chemical Regulations, such as REACH and Biocide.
- Perform hazard, exposure, and risk assessments, as well as efficacy assessments, in your field of expertise.
- Coordinate the preparation of application dossiers for the chemical industry with our subject matter experts.
- Communicate and collaborate closely with clients and competent authorities.
- Support project management and existing client relationships.
- Stay up-to-date with the current and future regulatory landscape, attending conferences and keeping abreast of developments in relevant laws and guidance.
- Provide industry expertise to support business development activities.
Requirements:
- Strong academic background with a relevant science-based degree.
- Prior experience in product regulatory affairs and product stewardship, or evidence of working in a related field.
- Knowledge and understanding of regulatory affairs, especially European regulations governing product safety and stewardship.
- Knowledge of EU and GB chemical regulatory requirements and/or global regulatory requirements.
- Strong project management skills.
- Experience with IUCLID 6 and human or environmental exposure models.
- Proficiency in IT packages, including MS Word, MS Excel, and MS Outlook.
- Fluent in English, with other languages an asset.
Personal Qualities:
- Self-starter with an entrepreneurial mentality.
- Strong analytical abilities and professional demeanour.
- Excellent organisational skills and ability to work well within a diverse team.
- Strong interpersonal skills and a flexible outlook.