Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Clinical Regulatory Manager
Start: 1/3/14
Length: 6 months
Location: South of Brussels
FUNCTION DESCRIPTION:
Description:
Clinical Regulatory Manager is accountable for ensuring that the Regulatory submissions related to the clinical data are of highest quality and meet scientific and regulatory standards.
Clinical Regulatory Manager is responsible for providing deepregulatory expertise in a particular regulatory field/area and/orrelated to the clinical development of a product.
Clinical Regulatory Manager is responsible for writing and reviewing the clinical sections of regulatory submissions (eg major variations, base dossier, paediatric investigational plan, ScientificAdvice).
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-cyclemanagement.
* 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 regulatorydocuments) Ensures that clinical sections of regulatory documents arein line with regulatory policies/guidelines.
* Ensures dissemination of knowledge of regulatory guidelines, adviceand 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 liaiseclosely 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 toregulatory questions related to clinical development and labelling.
- Very broad knowledge is required covering scientific as well asregulatory expertise.
- Scientific includes: medicine, biology, infectious diseases, immunology, clinical trials management, statistics & epidemiology.
- Expert understanding of pharmaceutical regulation and newguidelines/policies, and its application to the relevant productinformation: guidelines, legislation, registration procedures including
labelling, regulatory authorities across the different regionsof 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 company's 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 submissionof all documents relevant to support submissions
(license applications/Life Cycle) through close collaboration with Matrix teams for assigned projects.
Experience in regulatory requirements and management/organizationalskills are needed to allow management of transversal interactions withcontributing 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 developcredibility 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, Manager, Clinical, Pharmaceutical, Pharmaceutique,