Regulatory Portfolio Manager job in Uxbridge, England

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Project Manager

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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