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Regulatory Affairs Manager

Req #: 1801057
Location: Braine-l’Alleud, Brussels-Capital Region BE
Job Category: Regulatory Affairs
Work Location: Parc de l’Alliance Building D-E – Bloc E1 CELGBEL 1420
Organization: Celgene Belgium BVBA
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Belgium- Braine-l'Alleud

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary

The Manager Regulatory Affairs (MRA) is a local role based in the BeLux affiliate. The MRA reports to the Regulatory Affairs & Healthcare Compliance Director BeLux (RHCCD). The MRA is responsible for the activities related to Regulatory Affairs (including Risk Minimization Activities)Good Distribution Practices (GDP) and Health Care Compliance under the supervision of the RHHCD.

The outputs include:

  • Review and approval of local labelling texts for approved products and labels for investigational products.
  • Local RMP submissions and approvals to the national Health Authorities.
  • Local Regulatory submissions (CTA, Medical Need Programs (MNP), Compassionate Use Programs (CUP), Scientific Advice requests, ..).
  • Local Quality Management System with adequate management of procedural documents and training.
  • Packaging and waste declaration towards competent regional authorities.
  • Yearly disclosure of Transfers of Value towards Health Care Professionals and Health Care Organizations on betransparent.be (Belgium) and relevant Celgene website (Luxembourg).
  • Self-inspection of the affiliate on compliance with regulatory, quality and ethical standards and procedures.

Role and Responsibilities                               

Regulatory Affairs

Local Health Authority contact

  • Ensure effective and robust relationships with National Competent Authorities (NCA’s) for Belgium and Luxembourg.
  • Act as the point of contact for National Regulatory matters.
  • Support Regulatory Affairs Europe with local activities: NCA meetings (Rapporteurs meeting, RMP discussions, Scientific Advice).
  • Follow up of Regulatory activities for local requirements of centralized procedure.

Regulatory activities

  • Labelling: strategic input and qualitative review of labelling materials in local language(s), ensuring compliant implementation in the BeLux affiliate. Communicate availability of new prescribing information to relevant personnel of the affiliate, ensuring the old prescribing information is no longer used.
  • Clinical Trial Applications (CTA’s) and MNP’s/CUP’s: submission for approval to the NCA’s and provide input from legislative perspective to the international CT group.
  • Follow up of Regulatory activities for local requirements of centralized procedure such as DHPC letters to HCP’s.
  • RMP: Submit and obtain approval for new RMP’s and relevant updates from the NCA’s.

Quality Compliance

Act as a Responsible Pharmacist and assume responsibility in performing following activities:

  • Ensure oversight on the implementation and maintenance of the local Quality Management System (QMS) including all functions and responsibilities.
  • Develop and maintain local quality documents and quality assurance processes (SOP’s).
  • Oversee all quality system documents and training for all local personnel (including appropriate filing) and manage the ComplianceWire administrator for the affiliate.
  • Manage Product Quality Complaints (PQC), product returns and product recalls in accordance with local and global procedures and GDP standards.
  • Audits and inspections: prepare local affiliate and ensure adequate documentation and SOP’s are in place and local staff is adequately trained.
  • Supervision of the activities of the Local Service Provider to ensure compliance with GDP standards.

Health Care Compliance (HCC)

  • Act as back-up to the Nominated Signatory: Qualified Person for Information and Publicity (Royal Degree 07/04/1995).
  • Review of promotional materials for dedicated products.
  • Develop and maintain local HCC procedures (SOPs) and ensure appropriate documentation to demonstrate compliance with these processes.
  • Work in close collaboration with Legal department and with the Geographically Appointed Lawyer (GAL) on legal aspects of HCC.
  • Keep oversight on the yearly disclosure of Transfers of Value to Health Care Professionals and Health Care Organizations, in line with local regulations and deontological codes, by ensuring appropriate processes are in place to capture local data.

Skills/Knowledge required

  • University degree required with a strong preference for a Pharmacist or relevant related experience.
  • At least 5 years experience in the Pharmaceutical Industry.
  • A minimum of 2 years experience required in a Regulatory Affairs, Risk Management, Health Care Compliance and quality systems environment.
  • Knowledge of local regulatory requirements and of local drug regulations, relevant sections of the EU regulations and directives and ICH guidelines, local ethical codes of conduct (deontology).
  • Legal recognition by the Belgian Health Authorities as responsible person in the framework of Royal Decree of 07/04/1995 (responsible for information and publicity).
  • Additional experience with European Regulatory Affairs and EMA/Centralized Procedures is an advantage.

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