Head of RA

Job title : Head of RA
Location : Milano, Milan (province)
Job type : Permanent
Salary : Up to £0.00 per annum
Contact name : John Spring
Contact number : +44 (0) 207 255 6650
Contact email : john.spring@secpharma.com
Head of Regulatory Affairs (Remote Based in Europe)

This is a fantastic opportunity for a highly experienced and senior RA professional with a passion for life sciences. The company are an Italian pharmaceutical research organisation with a global outreach, improving the outlook of millions of patients' lives.

Salary & Benefits:

Excellent salary and benefits on offer (details on specific locations available on request)

Role and responsibilities:

-Leadership of the Regulatory Affairs organization at a global level;
-Management of high quality submissions leading to timely approvals;
-Lead and develops a local and/or global regulatory strategy that is reflective of local and international requirements;
-Lead development and implementation of innovative strategies to maximize the likelihood of regulatory success;
-Lead oversight and accountability for global regulatory operations;
-Oversight of all project strategy with global project teams;
-Oversight of effective planning, organizing, and conduct of formal meetings with regulatory agencies including advisory committee meetings and other scientific and development meetings;
-Leadership of regulatory strategic development, communication and updates and ensurance appropriate consultation and peer review;
-Provision of RA leadership in early development and due diligence projects;
-Collaboration with EU regulatory to develop global regulatory approval strategies
-Provision of regulatory guidance to project teams, ensuring that submissions meet regulatory requirements

Requires skills and qualifications:

- Degree level education in a scientific discipline
- 5+ years' experience in clinical research
- Strong knowledge of the European regulatory legislation and authorities (US or Asian experience is a nice to have)
- Knowledge of GCP guidelines
- Good knowledge of English language
- Good planning and organizational skills
- Able to manage multiple activities and different priorities simultaneously
- Able to interact with Sponsors and Competent Authorities




To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650