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Regulatory Affairs Registration Manager

Eingestellt von Harvey Nash IT Recruitment Belgium

Projektbeschreibung

For one of our clients in the pharmaceutical industry, we are currentlylooking for a Regulatory Affairs Registration Manager

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

FUNCTION DESCRIPTION:

Daily tasks will be related to the regulatory management of products.Role will be to manage filing of variations worldwide including Europeand resolve supply related issues.
It may involve both maintenance of dossiers as well as new dossiersubmissions.
The person will be required to communicate both internally andexternally, and maintain and update various databases and planningtools associated with the role.

KEY RESPONSIBILITIES:

o Be responsible for Registration activities of one or several projects
o Coordinate, prioritize and plan all the registration activities forthe projects within area of responsibility
o Work to the agreed strategy and actively take steps to ensure thedeadlines are met.
o Identify key issues on registration activities that could preventachieving objectives and pro-actively propose solutions.
o Ensure the plans are updated and communicated appropriately
o Communicate with external regulators on specific enquiries
o Maintain close contacts with the LOC's to ensure shared objectivesare achieved
o Exhibit a solid understanding of the global regulatory legislation,particularly relating to administrative and procedural aspects.
o Good understanding of Global Regulatory requirements and developspecialization in some areas of the RA regulations.
o Participate in (or lead) the development of the SOPs and guidelines,be trained, be a good relay to develop the awareness within the team,
act sometimes as a trainer and follow Company procedures appropriately.
o Participate in (or lead) the Regulatory Interface Team and givesfeedback on their specific areas of expertise

PREREQUISITES:

Education: University degree (preferably biological/chemical)

Knowledge:

Knowledge of Regulatory legislation in at least one geographic area
Basic understanding of biologicals/vaccines

Experience:

Ideally more than 4 years experience in the pharmaceutical industry;this should include at least 3 years RA experience.
Proven ability to manage typical regulatory activities, resolveproblems and deliver results

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Harvey Nash IT Recruitment Belgium