Regulatory Affairs Manager - CTA
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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.
- 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 email@example.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.