Regulatory Affairs Associate

1 month ago

Cambridge, United Kingdom Proclinical Full time

Proclinical are recruiting for a Regulatory Affairs Associate - II to join a pharmaceutical organisation. This role is on a contract basis and is located in either Cambridge or Uxbridge with hybrid working available.

**Responsibilities**:

- Conduct workflows and processes concerning document tracking, indexing, retrieving, and disseminating information to others when required.
- Partake in the process improvements and/or any other special projects in regulatory affairs linked to clinical trials.
- Assist with expediting and improving regulatory CTA administrative actions by mentoring and advising new or less experiences personnel.
- Help with inspection promptness actions when suitable.
- Guarantee that own work complies with formed practices, policies and procedures, as well as any regulatory or any other necessities.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Familiarity working in an administrative role within a corporate or linked business work setting, preferably within a healthcare sector or educated with a degree level in a scientific field is desirable.
- Acquaintance with regulatory CTA connected work experience assisting medicinal products.
- Previous involvement authoring or updating procedures would be ideal.
- Able to learn quickly as well as be flexible and adaptable to change, move between projects easily as well as offer aid/knowledge where required.
- Know-how of regulatory CTA needs and the role of regulatory affairs as these pertain to medicinal product clinical trials, which involves comprehension of ICH standards and contrasting regional needs in the allocated markets.
- An organised individual with a high attention to detail.
- Computer literacy.
- Project management abilities with the capacity to handle various tasks concurrently without compromise to timelines or quality of work.
- Communication skills both verbally and in writing as well as clear and concise.
- Works well in a team within a highly matrixed setting.

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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