Senior Regulatory Consultant - Oncology
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.
- 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.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on firstname.lastname@example.org.
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.