Senior Regulatory Affairs Specialist
5 days ago
We are seeking a highly skilled Senior Regulatory Affairs Consultant to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will be responsible for providing subject matter expertise in chemical legislation, developing authorisation strategies, and compiling approval/authorisation dossiers.
Key Responsibilities:
- Provide subject matter expertise in chemical legislation, including EU and GB Chemical Regulations (e.g., REACH, Biocide)
- Develop and implement authorisation strategies for clients, including development of testing programmes for industrial chemicals
- Compile approval/authorisation dossiers according to EU and GB Chemical Regulations
- Perform hazard, exposure, and risk assessments, and/or 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 with clients and competent authorities
- Support project management and existing client relationships
- Stay up-to-date with current and future regulatory landscapes, attending conferences and workshops to maintain expertise
- Provide industry expertise to support business development activities
Requirements:
- Strong academic background with a relevant science-based degree
- Relevant professional experience or qualifications in product regulatory affairs and product stewardship
- 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 (e.g., Chesar, EUSES)
- Proficiency in 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 and organisational skills
- Ability to work well within a diverse team and demonstrate strong interpersonal skills
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