Celgene Associate Manager Regulatory Affairs / Quality Assurance - Nordic region in Sweden, AlbertaSweden
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.
The Associate Manager Regulatory Affairs is a local role based in the one of the Nordic affiliates covering the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden). The Associate Manager Quality Assurance is responsible for managing the Nordic Quality Management System (QMS) to ensure compliance with local GDP regulations, as well as being the deputy Responsible Person (RP) for wholesale dealer’s licenses (WDL) in the Nordic countries, where needed.
In addition, the Associate Manager Quality Assurance will support the Regulatory and Compliance related activities under the supervision of the Associate Director, Regulatory, Quality and Compliance Nordics.
Role and Responsibilities
- Acts as deputy Responsible Person (RP) for WDL in the Nordic countries where needed according to local legislation, ensuring that the conditions of the WDL are met and that the guidelines on Good Distribution Practice (GDP) are complied with.
Support the Responsible Person (RP) in performing the following activities:
Oversees and is accountable for develop and maintain local GDP quality documents and quality assurance processes (SOP’s).
Ensure oversight on the implementation and maintenance of the local GDP Quality Management System (QMS) for the Nordic countries, and to regularly review and monitor all areas relevant to GDP.
Oversees the organization and documentation of all GDP quality system documents as well as planning and execution of GDP training of all relevant local personnel.
Accountable for the management of Product Quality Complaints (PQC), product returns and product recalls in accordance with local and global procedures and GDP standards.
Supervision of the activities of the Local Service Provider to ensure compliance with GDP standards.
Audits and inspection readiness: prepare local company and ensure adequate documentation and SOP’s are in place and local staff adequately trained on GDP standards.
Keeping abreast of national and international GDP standards.
Local Health Authority contact.
Support effective and robust relationships with National Competent Authorities (NCA’s) in the Nordic countries.
Support National Regulatory matters towards the NCA’s in the Nordics.
Support Regulatory Affairs Europe with local activities such as NCA meetings (Rapporteurs meeting, Scientific Advice) CTA discussions, Regulatory advocacy planning.
Support the follow up of Regulatory activities and strategies for local requirements of centralized procedure.
Labelling : strategic input and qualitative review of labelling materials in local language(s), ensuring compliant implementation in the Nordic affiliate. Communicate availability of new prescribing information to all personnel of the affiliate, ensuring the old prescribing information is no longer used.
Clinical Trial Applications (CTA’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.
Support the budget planning and follow up for Regulatory activities in the Nordic countries
- Act as back-up to the Compliance officer, in the approval of all promotional materials in the Nordics according to applicable legislations and guidelines.
University Pharmacy degree (licence not required).
Experience in the Pharmaceutical Industry.
Experience in a Quality Assurance 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.
Additional experience with European Regulatory Affairs and EMA/Centralised Procedures is an advantage.
Detail-oriented, excellent priority setting and strong analytical and diagnostic skill.
Ability to anticipate problems, be able to suggest solutions and implement appropriate procedures.
Excellent interpersonal skills, can work independently as well as contribute to the team.
Communication skills (written and oral).
Strong identification with Celgene’s values.
Fluent in English and one or more of the Scandinavian languages.
Associate Manager Regulatory Affairs / Quality Assurance - Nordic region
Location: Sweden, AB, SE
Job ID: 17000910