Regulatory Affairs Scientist

Job Purpose:

To provide regulatory consultancy services to internal and external clients, including preparation, review, submission and project management of regulatory applications.

Main accountabilities:

• Maintain an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department.
• Provide up to date regulatory advice to internal and external clients as required. Prepare, review, submit and project manage regulatory submissions in compliance with the applicable company SOPs, regulatory guidelines and legislation. Attend client project meetings (face to face and via teleconference) as required. Maintain electronic and hard copy project and regulatory files. Participate in business development activities as required. Provide input into monthly invoicing.
• Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers. Maintain high levels of customer service to meet client expectations at all times.
• Technical/Specialist A sound understanding of one or more scientific disciplines related to manufacturing, non-clinical or clinical development of pharmaceutical/healthcare products

Desirable Skills:

• Competent IT skills including the use of MS Office applications Word, Excel, Powerpoint and Outlook
• Experience from working in a pharmaceutical/healthcare product development environment. An overall understanding of the drug development process and the role of regulatory affairs within that process

All employees have certain shared responsibilities and these include:

- to maintain and promote the reputation of the company as an ethical and expert consultancy company- to maintain the confidentiality of patient, client and company information- to maintain good professional relationships with all external parties in contact with the company, including clients, suppliers, consultants and clinical trial investigators- to maintain good working relationships with colleagues and to enable a team spirit within the company- to contribute ideas on matters affecting the running of the company- to maintain an awareness of the business of the company and of all ongoing projects- to be organised in the planning of personal workload- to ensure that person development is maintained through continuous training assessment- to maintain technical expertise as appropriate- to be conversant with the company Standard Operating Procedures

Even if you are unsure on your suitability for this position but you are looking at the possibility of some progression in your current job or a change in your career path, please feel free to contact me for a friendly chat to explore any options that may be open to you.All enquiries will be dealt with in a strictly confidential manner. Call Matt on 01293 776644 or email me at mhart@barringtonjames.com