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.

Responsibilities:

• 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 p.duvall@proclinical.com.

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.

#Regulatory