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Regulatory Affairs Officer
ECO Animal Health, an international developer, manufacturer and distributor of veterinary pharmaceutical products, is seeking an individual to co-ordinate and manage our product registration portfolio in international/emerging markets, excluding the EU and USA.
Maintain and update existing Marketing Authorisations (MAs) in these regions
Prepare new dossiers in accordance with local legal requirements
Ensure submissions to regulatory authorities, including data compilation and argumentation, are to the required standard and delivered to an agreed timeline
Maintain effective communications with the regulatory authorities and in-country agencies and respond to questions from the authorities in a timely fashion
Ensure that ECO product packaging and datasheets are consistent with the MAs and local regulations
Maintain awareness of the regulatory requirements of the various authorities in the regions
Develop and lead discrete projects to respond to changes in the regulatory environment
Knowledge and skills required
Scientific background (Chemistry, Biological or Animal Sciences degree), preferably with experience of regulatory affairs or similar in the veterinary or related field. Must be self-starting, have good communication, organisational and IT skills and be able to work well in a multi-disciplinary team.
This is an excellent opportunity to join an enthusiastic team working in a progressive company, based in our North London offices. The job title and remuneration will be based on previous level of experience. The person appointed will report to the Senior Regulatory Affairs Manager.
Please apply with a CV and covering letter to ECO Animal Health, PO Box 47542, London N14 6WS. E-mail: firstname.lastname@example.org.