Clinical Regulatory Manager

Brussel  ‐ Onsite
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Keywords

Description

One of our clients, a multinational company in the pharmaceutical industry currently requires a Regulatory Manager for the Clinical department

Start: ASAP
Length: min 6 months
Location: South of Brussels

FUNCTION DESCRIPTION:

- accountable for ensuring that the Regulatory submissions related tothe clinical data are of highest quality and meet scientific and regulatory standards.

- responsible for providing deep regulatory expertise in a particular regulatory field/area and/or related to the clinical development of aproduct.

- responsible for writing and reviewing the clinical sections ofregulatory submissions (eg major variations, base dossier,paediatric investigational plan, Scientific Advice).

KEY RESPONSIBILITIES

The role is complex & broad and it includes:

* Quality Control of the clinical sections of regulatory submissions
* Provides regulatory guidance to ensure the integration of regulatory requirements at all stages of clinical development and life cycle management.
* Building of Clinical Regulatory expertise and knowledge base.
* Interacts with other departments (Clinical, VCSP) to ensure harmonized file contents and submissions.
* Providing writing support for projects based on strategic resourcing request (Clinical Overview and other regulatory documents)
Ensures that clinical sections of regulatory documents are in line with the clients and regulatory policies/guidelines.
* Ensures dissemination of knowledge of regulatory guidelines, advice and expertise to relevant departments/teams.
Ensures that all relevant policies and standard operating procedures (SOP) are respected
* Assessment and interpretation of new regulations, guidelines andpolicies and facilitation of their implementation within the department.

Clinical Regulatory Manager needs to be proactive in on-going andfuture developments within the regulatory environment and liaise closely with the different groups within the Regulatory organization,
to ensure a harmonized approach between different groups/projects.

PREREQUISITES

Education:
- Advanced Scientific Degree, preferably Ph.D or relevant experience

Knowledge/Experience:
- At least 5 years experience in pharmaceutical industry or at least 3 years experience in regulatory affairs
- Active participation in file preparation or variation, answer to regulatory questions related to clinical development and labelling.
- Very broad knowledge is required covering scientific as well as regulatory expertise.
- Scientific includes: medicine, biology, infectious diseases, immunology, clinical trials management, statistics & epidemiology.
- Expert understanding of pharmaceutical regulation and new guidelines/policies, and its application to the relevant product information: guidelines, legislation, registration procedures including labelling, regulatory authorities across the different regions of the world.

A Regulatory professional presents high level of autonomy, together with a strong scientific expertise. The job requires management ofhighly scientific matters, interactions with the client community
at large (eg clinical, VCSP, RA Product and Functional Experts etc).Combined with Regulatory Affairs expertise, this would facilitate the job main purposes ie the writing, review, preparation and
submission of all documents relevant to support submissions (license applications/Life Cycle) through close collaboration with Matrix teamsfor assigned projects. Experience in regulatory requirements and management/organizational skills are needed to allow management of transversal interactions with contributing stakeholders so to obtain the necessary information needed for "Right the First Time" submissions.

Skills:

- Evidence of proactive leadership to identify issues and maximise opportunities
- Ability to work in an international regulatory environment and in multidisciplinary teams
- Flexibility: able to work on different projects in line with tight timelines and according to business needs
- Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside the company
- Ability to resolve problems through resourceful use of informationand contacts
- Recognized excellent communication skills, both oral and written, fluent in English, with excellent writing skills

Tags: Regulatory, Clinical, Submissions, reports, regulation

Start date
n.a
Duration
6 months
From
Harvey Nash IT Recruitment Belgium
Published at
08.04.2014
Project ID:
691572
Contract type
Freelance
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