Regulatory Consultant

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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