Senior Regulatory Consultant

2 weeks ago

Uxbridge, United Kingdom Proclinical Full time

Proclinical are recruiting for a Senior Regulatory Consultant - Oncology to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.

**Responsibilities**:

- Guide the development of regional regulatory documents and meetings rendering to GRT methods.
- Cooperation share regulatory information and implications with the GRT staff on an ongoing basis and offer advice on regional considerations.
- You will advise the GRT on regional considerations in developing method guaranteeing the regional requirements are well outlined and executed in cooperation with pertinent regional shareholders.
- Execute product linked regulatory methods, regulatory affairs procedures and action planning rendering to national legislation and regulatory needs.
- Discuss and guarantee alignment f regional management before GRT method decisions.
- You will document and discuss details and results of regulatory agency interactions to GRT and pertinent sr. management.
- Offer managerial leadership and direction to allocated team allowing suitable prioritisation of resources to accomplish objectives.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Regulatory expertise Regulatory knowledge in regional legislation.
- Familiarity operating with policies, process and SOPs.
- Acquaintance with national legislation and guidelines linking to medicinal products.
- Comprehension of the regional regulatory processes for CTAs, MAs, post approval alterations, extensions and renewals.
- Comprehension of drug development scientific/technical brilliance.
- Expertise on and prior involvement with regional regulatory setting in pertinent product area and development stage.
- Understanding of regulatory actions, touch points and how they affect projects and procedures.
- Capable of resolving issues and develop a course of action leading to a beneficial result.
- Cultural awareness and sensitivity to complete outcomes both regional country and global borders.

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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