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Regulatory Consultant
£45 - £55 per hour
- Contract
- Consultant / Specialist
- United Kingdom
Surrey, England
Posting date:
17 Aug 2023
56139
This vacancy has now expired. Please see similar roles below...
Proclinical are partnering with a pharmaceutical organisation who are recruiting for an individual to join their team. The opening position available is for a Regulatory Consultant. This role is on a contract basis and is located in Surrey.
Responsibilities:
- Handle and submit MA variation applications as well as MA renewal applications.
- Collaborate with country operational hubs and tacticians, respond to regulatory authority queries and contribute to aggregate safety reports.
- You will respond to natural requests from authorities promptly and precisely.
- Form personal knowledge through management of specified products in one or more therapy areas.
- Mediate with clinical research project managers in searching to comprehend clinical research program.
- Collaborate with regional tacticians to offer country contributions into international and European methods when needed.
- The ideal candidate will prepare agreed module 1 documents in collaboration with above-country operational hubs.
- Evaluate and approve suggested regulated documents such as SPC, PIL and Labelling and affiliated network aligned with guidelines.
- Other duties to be assigned.
Key Skills and Requirements:
- Educated to a degree level in a life science or chemistry field.
- Ideally educated to a Masters Degree, Post Graduate Diploma or PhD degree level.
- Pertinent professional qualifications would be preferable such as an MSc in regulatory.
- Acquaintance with regulatory such as human medicinal products.
- Are a member of the organisation for professionals in regulatory affairs are desirable.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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