Our client is seeking a self-motivated individual with knowledge and experienced in working in a Regulatory environment, who is able to work under pressure and tight deadlines while maintaining a very high standard of attention to details, while dealing with a diverse range of internal and external customers and Regulatory bodies.
Primary Duties and Areas of Responsibilities:
- Liaise with the Commercial Export Manager to ensure the regulatory aspects for exporting of products are fully assessed and are complied with.
- Liaise with the local distributor/agent to ensure the process is fully understood by both parties and liaise where necessary with the regulatory authority to enable full comprehension of requirements specific to the area.
- Prepare project plans to support the submission of the product licences applied
- Manage the process for the local registration of client as a manufacturing site in the specified country/region.
- Co-ordinate and prepare reports to Regulatory Agencies in response to requests for further information after assessment of submissions.
The Export Regulatory Officer will have BSc or MSc in life sciences related discipline with 2-3 years’ experience of working within Regulatory industry and have understanding & experience of GMP. The applicant will be expected to have good IT skills – use of Adobe Acrobat Professional, eCTD, submission software. Self-motivated, ability to deal with conflicts in demand, time constraints and deadlines, as well as, excellent written and presentation skills.
To apply for this position, candidates must be eligible to live and work in the UK
You must be eligible to work in the UK. Learn more
- Agency: ST Recruitment
- Contact: Sam
- Phone: 01737 241823
- Reference: RTP20
- Updated: 29th March 2019
- Expires: 26th April 2019