Regulatory Affairs Specialist

Job Type:
Job Sector:
Epsom, Cambridge, Yorkshire
£50,000 to £50,000 per annum
Salary Description:
£50000 - £50000 Per Annum
Additional Resources
Job Ref:

Regulatory Affairs Specialist - Epsom, Cambridge, Yorkshire

Salary - up to £50k + Pension + Healthcare + Life Assurance + Mobile

The Client

This highly successful business provides independent advisory and advanced product development services focused on science and technology initiatives. Our client's specialist companies, collaborate closely with their clients to deliver clear returns on technology, R&D and regulatory investments.

The company prides itself on its proven track record in providing the highest possible professional standards in regulatory and scientific services to the chemical and biotechnology industries. The multidisciplinary team of scientists, regulatory and registration specialists allows them to provide support across a range of areas, including strategic advice, data gap analysis, biocidal product family development/construction, dossier preparation and submission and task force/consortia management. The company have extensive experience in dealing with regulators and with their network of regional offices; they provide a pan-European product registration service.

The Role

As a Regulatory Affairs Specialist, you will be responsible for advising on, and structuring solutions that guide the clients successfully through the complex regulatory and policy challenges within the EU. The broad scope of the work will challenge you to provide successful regulatory outcomes on applications for new active substances, and renewals of existing active substances, under Regulation (EU) 528/2012 (BPR) and in managing product registrations under National (transitional) rules and BPR (including product families).

Key responsibilities include:
Client management & delivery
Plan, co-ordinate and deliver high quality work in an efficient and effective manner to meet deadlines, ensuring client satisfaction and enhancing long-term client relationships
Advise and support clients through the regulatory process, including provision of guidance on strategy, preparation of product registration applications, collation of biocidal active substance and biocidal product dossiers, and use of ECHA IT tools such as IUCLID and R4BP.
Engage in interactions with regulatory authorities and relevant industry bodies in conjunction with the client as required.
Regularly communicate with clients and the project team to ensure client requirements are understood and expectations are met
Develop and maintain a comprehensive understanding of the current and future regulatory landscape.

Business development
Provide support to business development activities by providing industry expertise when needed during visits to clients, through discussion and responses to new project briefs and administration.
Work with colleagues to foster a collaborative and cooperative environment not only within your business area but also focusing on developing links with other business areas in the Group

Project guidance
Engage and work with multi-disciplinary teams, including geographically dispersed teams based in other countries/Member States to help deliver client outputs.
Support members of your project team and colleagues in providing advice to clients and in relation to any project issues they may encounter

The ideal candidate would also be responsible for:

Microbiology/efficacy specialist support
Knowledge on microbiology and CEN standards
Assist with the completeness/quality review of scientific data according to current Europe

Contact Details:
Additional Resources
Tel: 0845 450 6635
Contact: Hamera

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