Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
About the role
- Provide ecotoxicology and REACH risk assessments for agrochemical and biocide clients at ERM; support dossiers, client meetings, and regulatory submissions.
Responsibilities
- Provide a high quality consultancy service in ecotoxicology and environmental risk assessment to clients and ERM staff
- Understand clients’ desired outcomes and work collaboratively to ensure deliverables meet quality standards
- Work closely with clients, represent ERM in client meetings and respond to specific questions on ecotoxicology
- Contribute to commercial growth through business development activities (client visits, conferences, expert groups)
- Undertake evaluation and summarisation of ecotoxicology data, ecological risk assessments and ecotoxicology study monitoring, focusing on REACH requirements
- Ensure awareness of latest developments in ecotoxicology and ecological risk assessment
- Collaborate with environmental fate, mammalian toxicology and other ecotoxicology experts on projects
- Define actions, identify and utilise resources to deliver projects on time and to budget
- Develop expertise in new EU regulatory developments
- Assist in personal development of other team members and undertake scientific/administrative tasks as needed
Requirements
- Educated to at least degree level within Biology, Ecotoxicology or a related field
- Proven experience in conducting ecotoxicological risk assessments
- Demonstrated ability to design and conduct ecotoxicology studies
- Strong knowledge of relevant EU regulations and guidelines, including EU data requirements for ecotoxicology studies
- Practical experience of communication and liaison with EU regulatory bodies (Member States, ECHA etc.) and involvement in expert meetings with clients
- Demonstrated ability to work in a collaborative environment and across disciplines
- Fully experienced in the preparation and support of dossiers using appropriate software (IUCLID, CHESAR) with a focus on REACH submissions
- Strong commitment to delivering high quality work and to safety (Health and Safety protocols)
- Excellent communicator (written/verbal) with the ability to listen, organise and prioritise
- Proficiency in ecotox statistical analysis software is preferable
- Experience in non-EU regulatory requirements (Lat. Am, North America, APAC) would be considered an asset
- Prior experience in participation in advocacy groups
- Excellent inter-personal skills
Benefits
- Flexible hybrid working model
- Flexibility
- International group of experts across regions
- Growth in new areas
- Opportunities for ongoing development across technical, business, and personal areas
- Competitive remuneration
- Various office locations
- Inclusive workplace with accommodations and support for candidates with disabilities and neurodiversity
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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