The leading specialist in Dermatology is currently looking for a Regulatory Affairs Officer to join their team based in Manchester, North West, UK.
As the Regulatory Affairs Officer you will provide regulatory support and assistance in line with the Registration Program in order to ensure the company maintains compliance whilst at the same time meets its business objectives.
Further key tasks assigned to the Regulatory Affairs Manager will include:
- Responsibility for the timely preparation, submission and follow up of regulatory submissions to Competent Authorities, in line with the Registration Program, as defined by the Registration Manager.
- Ensure that all Clinical Trial Applications / IND Applications as approved by the Regulatory Authorities are compliant with current company working practices and legislation, which includes active involvement in the Company Change Control Procedure and the tracking of all trials.
- Provide regulatory information, guidance and support to the R&D, Commercial, Clinical and Quality functions with respect to the development of Company products.
- Take responsibility for monitoring guidance and legislative requirements with respect to the preparation and submission of the registration dossiers using eCTD.
- Maintain a knowledge and familiarity with current regulatory requirements for all aspects of the job.
The ideal candidate for this Regulatory Affairs Officer job will be educated to degree level or equivalent in pharmacy, pharmacology or the biological or chemical science, along with experience in pharmaceutical and/or biotechnology regulatory affairs. In addition, this Regulatory Affairs Officer job demands a candidate with the following skills and competencies:
- Ability to work as part of a multi-disciplinary team.
- Good organisation and time management skills.
- Good written and verbal communication.
- Good flexibility and adaptability.
- Strong desire to achieve optimal results.
- Basic computer skills and knowledge of relevant software packages.
For more information or to apply for this Regulatory Affairs Officer job, please contact Jonathan Hart-Smith on 01438 743047 or email firstname.lastname@example.org.
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