Regulatory Portfolio Manager
Proclinical are recruiting for a Regulatory Portfolio Manager to join a biopharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.
- Guide or serve as a representative for RPM on GRS and enterprise process initiatives to drive a culture of constant improvement and operational brilliance.
- You will engage with customers to develop RPM assistance.
- Serve as a representative as the global regulatory lead in the team when required.
- Arrange preparation of regulatory elements for US proposals and write allocated M1 documents.
- The ideal candidate will assist and arrange preparations for FDA meetings.
- Collaborate with the global regulatory lead and broader global regulatory sub-team to distribute and implement the optimal regulatory method for allocated asset(s).
- Responsible for developing and upholding the asset's international regulatory book of work and international submission plan which involves mediating cross-functionally to produce periodic internal milestone reports.
- Evaluate prior health authority queries to lead response development.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a healthcare connected discipline or work experience in that field.
- Regulatory familiarity with developing expertise on US and/or EU processes.
- Works well independently within an international matrix setting with the capacity to efficiently prioritise workload.
- Able to assume responsibility for delivery.
- Capable of guiding through influence and forming alignment with shareholders to deliver projects to plan.
- A constant improvement mindset with the ability to resolve issues.
- Deliberation, interpersonal and communication skills both verbally and in writing.
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.