WE TAKE  THE
FRESH APPROACH

by nature

Home > Talents

Regulatory Affairs Manager

Company/Department


As a RA manager your daily tasks will be related to the regulatory management of products (Vaccines). Your role will be to project manage filing of variations worldwide and to resolve supply related issues as well as the management of the content of relevant technical/CMC sections of project and product specific documents submitted to regulatory agencies worldwide. It may involve both maintenance of dossiers as well as new dossier submissions. you will be required to communicate both internally and externally, to maintain or update various databases and planning tools .

The position will be for a six month period and would be based in Wavre, Belgium.


Function information


The role has the following responsibilities:

 

  • You will provide support to the supervisor for key regulatory activities pertaining to a project and product.
  • Interact with or represents his internal project related teams for technical/ CMC and procedural aspects of a given project.
  • Participate to project and product-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of given project.
  • Provide in-depth input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects.
  • Provide support to the supervisor via critical review of the technical and procedural section of regulatory documents
  • Coordinate (for technical/CMC and procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with supervisor
  • Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements.
  • Provide input to Vaccines Development Plans in order to optimize the label by use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for technical/CMC and procedural aspects.
  • Facilitate and deliver the regulatory strategy to support the life-cycle of the asset; contribute for technical/CMC and procedural aspects.
  • May possibly act as the point of contact for Regulatory Agencies for assets.
  • Provide support to the supervisor to assure efficient interactions with the regulatory authorities to achieve on-time approvals of the Company’s Vaccines submissions for the assets.
  • Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular assets.
  • Develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
  • Ensure planning and proper organization of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.

Requirements


Education:

Ph.D. degree (preferably biological/chemical)

Language:

ENGLISH: perfect command

Hard Skills:

Knowledge of Regulatory legislation in different geographical areas

Understanding of biologicals/vaccines

Experience :

Ideally more than 3 years’ experience in the pharmaceutical industry; this should include at least 1 year

experience in regulatory (CMC/procedural).

Soft skills :

Proven ability to manage typical regulatory activities, resolve problems and deliver results

Good communication skills – Team spirit


Offer


Working as a consultant for XPE Pharma & Science means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.


Information


Carine Steurs

carine.steurs@xpepharmascience.com

010.80.71.03


Interested in this job?

APPLY NOW

Not what you're looking for?


Spontaneous application

Haven't found the dream job you're looking for? Submit a spontaneous application now!

Spontaneous application
*}