Regulatory Affairs Manager - CTA job in London, England

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Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Project Manager

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Regulatory Affairs Manager - CTA to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from the UK.

Responsibilities:

Accountable for CTA proposals for phase III study, which involves evaluation of CRO drafted proposal documents, handling response to queries, and any other study regulatory actions.
Handle post-approval proposals for EU, GB, and Switzerland for a marketed product.
You will be accountable for handling EU scientific advice actions, which involves proposal of briefing document, meeting preparation, direct contact with health authorities, etc.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a scientific field, though an advanced degree would be ideal but not necessary for the role.
Demonstrable experience within regulatory affairs method.
Familiarity with haematology products would be preferable but other therapeutic areas will be taken into consideration.
Acquaintance engaging with regulatory authorities as the main point of contact on proposals and/or health meeting(s).
Exhibit a firm commitment to accomplishing corporate gals while upholding the highest ethical, regulatory and scientific standards.
A background in practicing sound judgment as it links to risk assessment.
Communication skills both verbally and in writing with the ability to be highly conversant.
Expertise on new and developing guidelines and regulations.
Comprehension of GMPs, GLPs and GCPs, as well as of where to seek and how to understand regulatory information.
Works well in a team.
Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at 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.

#Regulatory