Functieomschrijving Regulatory Affairs & Quality Assurance Specialist
The Specialist RA&QA is responsible to execute Regulatory Affairs & Quality Assurance tasks in the Netherlands. The Specialist will support the management of the Quality Management System (including SOPs) to ensure quality of all Celgene B.V. procedures and compliance with local regulations. The Specialist will support the Responsible Person(s) for GDP of the affiliate. In addition,. the Specialist will defend and maintain registration files (MAA) according to current legislation in the Netherlands. The Specialist will provide guidance to multidisciplinary teams (e.g. Disease teams) to ensure that all activities developed and performed are in compliance with applicable regulatory demands (legislations and guidelines) in coordination with the QA responsible person/team.
Responsibilities include, but are not limited to, the following:
- Develops and maintains regulatory knowledge of national and European regulations and legislations, including:
1. EU and local Dutch GDP, GCP, GMP and RMP requirements and
2. Local CGR guidelines.
- Manages, coordinates and follows up on regulatory activities and strategies related to a selection of products in the Netherlands. Negotiates and communicates effectively with both the corporate regulatory affairs group and the regulatory authorities to obtain timely product approvals.
- Keeps all employees informed of the effective version of the label for the relevant local marketed- products.
- Provides the senior management with key data from Regulatory affairs to help drive local decisions on a continuous basis & with recommendations concerning the regulatory strategy.
- Acts as regulatory representative on selected cross-functional teams.
- Participates in the approval process of all oral and written promotional or non-promotional items for external audiences according to the regulations and legislations in the Netherlands.
- Together with senior management supports the Market Access strategy where applicable from a RA perspective.
- Develops, initiates, maintains, and revises policies and procedures for the general operation of the Compliance Program (excluding HCC, but including but not limited to complaint handing, product recall, external audit and self inspection program, product returns) and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program.
- Develops and periodically reviews and updates the Quality Handbook to ensure continuing accuracy and relevance in providing guidance to management and employees.
- Manages a local Quality Management System, including the supporting systems.
- Identifies potential areas of compliance vulnerability and risk; develops/ implements corrective and preventive action (CAPA) plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
- Support the coordination of local audits and subsequent CAPA actions.
- Assists with respect to quality control in connection with pharmaceutical activities, specifically regarding recall operations, complaints and returns management, customer approval.
- Supports the communication with the Dutch Health Care Authorities regarding issues relating to pharmaceutical activities and products.
- Stimulates a culture of constant improvement of quality standards in the organization.
- Preferably university degree in a relevant scientific discipline (pharmacist is preferable) – however, candidate with the right profile from a “Hoge School” in Pharma or Healthcare may qaulify as well.
- Minimum of 3 years pharmaceutical industry experience in the relevant areas of regulatory and quality assurance.
- Specific expert knowledge in the area of regulatory affairs and preferably quality assurance.
- Must understand the principles of quality management and will be conversant with e.g. ICH Quality Guidelines Q9 and Q10, and EU Guidelines 2013/C 343/01 on Good Distribution Practice.
- Ability to build national networks and relationships.
- Proven influencing skills with trade associations & regulatory bodies.
- Anticipate trends/changes in regulatory environment.
- Advanced understanding of structure & workings of regulatory bodies in country assigned.
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes.
- Excellent communication skills (verbal and written) in Dutch as primary language. Very good in English.
- Domestic and International travel may be necessary.
My client is is an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. Headquartered in new Jersey and has an operation of around 80 people in The Netherlands.