Job Description

Novellas Healthcare

Recruiter Roxane Leloup
Belgium|Pharmaceuticals|-

Regulatory Affairs Manager

The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide products by ensuring the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities.

Description


The role has the following responsibilities:
 

  • Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
  • Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fulfilled
  • Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
  • Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
  • Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ensure deadlines are met
  • Maintain close contacts with the Local Operating Compagnies (LOC’s) to ensure shared objectives are achieved
  • Ensure the tracking of relevant correspondence with Authorities
  • Communicate with relevant parties:
  • Communicate with external regulators on specific enquiries
  • Communicate regulatory updated information to internal stakeholders
  • 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.
  • Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
     

Profile


  • University degree (preferably biological/chemical)
  • Ideally more than 3 years experience in the pharmaceutical industry; this should include at least 1-2 years RA experience.
  • Knowledge of Regulatory legislation in at least one geographic area
  • Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
  • Analytical capacity
  • Flexible work approach; enjoys a varied working day
  • Teamwork and collaboration
  • Can work under stress and to deadlines
  • An eye for detail
     

Offer


At Novellas Healthcare, we offer you a job in a dynamic work environment and a competitive remuneration package according to your experience.

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