Global Regulatory Affairs Consultant

For one of our clients in the pharmaceutical industry, we are currently looking for a Global Regulatory Affairs Consultant

Start: 1/5/13
Length: 6 months
Location: Wavre

FUNCTION DESCRIPTION:

The Position Holder (PH) will have global responsibility (for Regulatory Affairs) of given activities for DTP/dTpa product(s).

The purpose of the Mission is to:

* Provide input into the content of clinical/labelling sections ofDTP/dTp product specific documents submitted to regulatory agencies worldwide and ensure that these documents meet high scientific standards and regulatory requirements (eg review of Summaries of Clinical Efficacy, Summaries of Clinical Safety ).
* Provide clinical/labelling regulatory support to other functions inpreparation of DTP/dTp product specific documents (ie contribute tothe preparation and review of documentation from the Clinical, Safety,Medical Affairs and Commercial teams).
* Write sections of clinical regulatory dossier (eg Clinical Overview) for DTP/dTp projects.

KEY RESPONSIBILITIES:
The role includes the following responsibilities:
* Compile/write high quality clinical/labelling sub-sections of regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements, for the DTP/dTpproduct-line.
* Provide support to the line manager for key regulatory activities pertaining to the DTP/dTp product-line.
* Participate to DTP/dTp project/product-related discussions and provide scientific and RA input for clinical/labelling aspects of the given project.
* Provide input into clinical/labelling section/sub-section(s) for the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the line manager.
* For cross-product sections or stand-alone documents, work with the functional team to ensure content is aligned with targeted overall profile of the DTP/dTp product.
* Must possibly be aware of changes in regulatory guidelines and their impact on regulatory strategy for the DTP/dTp product-line.

TRAINING:
* On arrival - training for access to all relevant systems and focused training on preparation on regulatory documentation
* On the job - coaching on daily RA activities and on an "as-needed" basis.

EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED
Education
* Minimum level of education: Advanced Scientific Degree in the area of General Science or Life Science
* Preferred level of Education: Ph.D. or M.D. in the area of Pharmacy,Chemistry, Biology or Medicine
Experience/Knowledge
* Previous experience in writing scientific/regulatory documents.
* Broad knowledge is required and covers scientific as well as regulatory expertise.

Other Behaviors/Skills
* Fluent in English, with excellent writing skills.
* Able to write and critically review documents targeting internal orexternal audiences.
* Able to provide regulatory input and evaluate potential impact on respective regulatory submission(s).
* Able to identify and escalate issues to the line manager.
* Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner.
* Ability to resolve problems through resourceful use of information and contacts.
* Culturally aware.
* Quality mindset.